Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT00659269
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2008-04-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C067316', 'term': 'Geritol'}, {'id': 'D014805', 'term': 'Vitamin B 12'}, {'id': 'D025101', 'term': 'Vitamin B 6'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010847', 'term': 'Picolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zdayao@salud.unm.edu', 'phone': '5059250404', 'title': 'Zoneddy Dayao, MD', 'organization': 'University of New Mexico'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "The number of completed surveys decreased as time went on for each group of patients. This resulted in small numbers of patients to analyze, especially in Group 3 (Vinca Alkaloids), since there weren't many patients in this group to begin with."}}, 'adverseEventsModule': {'description': 'Since vitamin B6 and B12 are food supplements with only rare toxic effects, no toxicity will be recorded. Only serious adverse (SAE) will be reported, whether or not related to these vitamins.', 'eventGroups': [{'id': 'EG000', 'title': 'Multivitamin (MV)', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 157, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Multivitamin + Vitamin B12 + Vitamin B6', 'description': 'Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nCumulative doses (in mg/m2) are:\n\npaclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 162, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Neurotoxicity Assessment at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Taxane Group: Multivitamin (MV) Arm', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n\nRanges of cumulative doses (in mg/m2) are:\n\npaclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800'}, {'id': 'OG001', 'title': 'Taxane Group: MV + Vitamin B12 + Vitamin B6', 'description': 'Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nRanges of cumulative doses (in mg/m2) are:\n\npaclitaxel, 700-960; docetaxel, 240-400'}, {'id': 'OG002', 'title': 'Heavy Metals Group: Multivitamin (MV) Arm', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n\nCumulative doses for chemotherapy (in mg/m2) are:\n\ncisplatin, 240-400; oxaliplatin, 400-800'}, {'id': 'OG003', 'title': 'Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm', 'description': 'Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nRanges of cumulative doses (in mg/m2) are:\n\ncisplatin, 240-400; oxaliplatin, 400-800'}, {'id': 'OG004', 'title': 'Vinca Alkaloids Group: Multivitamin (MV) Arm', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n\nCumulative doses for chemotherapy (in mg/m2) are:\n\nvincristine, 8-16; vinorelbine, 360-480'}, {'id': 'OG005', 'title': 'Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm', 'description': 'Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nRanges of cumulative doses (in mg/m2) are:\n\nvincristine, 8-16; vinorelbine, 360-480'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '5.23', 'spread': '5.86', 'groupId': 'OG002'}, {'value': '4.58', 'spread': '5.34', 'groupId': 'OG003'}, {'value': '6.80', 'spread': '5.09', 'groupId': 'OG004'}, {'value': '2.08', 'spread': '2.02', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At study start; prior to treatment (week 0)', 'description': 'Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 92 and 97 patients in the MV arm and MV + Vit.B12 + VitB6 arm, 84 and 86 patients, respectively, in the Group 1 (Taxanes) completed the FACT-Tax questionnaire at baseline and the analysis is presented here. This also applies to 48 and 45 patients in Group 2 (Heavy Metals) and 10 and 12 patients in Group 3 (Vincas)'}, {'type': 'PRIMARY', 'title': 'Neurotoxicity Assessment at Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Taxane Group: Multivitamin (MV) Arm', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n\nRanges of cumulative doses (in mg/m2) are:\n\npaclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800'}, {'id': 'OG001', 'title': 'Taxane Group: MV + Vitamin B12 + Vitamin B6', 'description': 'Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nRanges of cumulative doses (in mg/m2) are:\n\npaclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800'}, {'id': 'OG002', 'title': 'Heavy Metals Group: Multivitamin (MV) Arm', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n\nRanges of cumulative doses (in mg/m2) are:\n\ncisplatin, 240-400; oxaliplatin, 400-800'}, {'id': 'OG003', 'title': 'Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm', 'description': 'Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nRanges of cumulative doses (in mg/m2) are:\n\ncisplatin, 240-400; oxaliplatin, 400-800'}, {'id': 'OG004', 'title': 'Vinca Alkaloids Group: Multivitamin (MV) Arm', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n\nRanges of cumulative doses (in mg/m2) are:\n\nvincristine, 8-16; vinorelbine, 360-480'}, {'id': 'OG005', 'title': 'Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm', 'description': 'Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nRanges of cumulative doses (in mg/m2) are:\n\nvincristine, 8-16; vinorelbine, 360-480'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '5.99', 'groupId': 'OG002'}, {'value': '8.4', 'spread': '7.16', 'groupId': 'OG003'}, {'value': '14.56', 'spread': '12.9', 'groupId': 'OG004'}, {'value': '5.6', 'spread': '6.59', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 92 \\& 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 72 \\& 80 patients, respectively, in the Group 1 (Taxanes) both completed 2 cycles of treatment and completed the FACT-Tax questionnaire at cycle 2, and the analysis is presented here. The same applies to 27 \\& 25 patients in Group 2 (Heavy Metals) and 9 \\& 10 patients in Group 3 (Vinca)'}, {'type': 'PRIMARY', 'title': 'Neurotoxicity Assessment at Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Taxane Group: Multivitamin (MV) Arm', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n\nRanges of cumulative doses (in mg/m2) are:\n\npaclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800'}, {'id': 'OG001', 'title': 'Multivitamin + Vitamin B12 + Vitamin B6', 'description': 'Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nRanges of cumulative doses (in mg/m2) are:\n\npaclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800'}, {'id': 'OG002', 'title': 'Heavy Metals Group: Multivitamin (MV) Arm', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n\nRanges of cumulative doses (in mg/m2) are:\n\ncisplatin, 240-400; oxaliplatin, 400-800'}, {'id': 'OG003', 'title': 'Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm', 'description': 'Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nRanges of cumulative doses (in mg/m2) are:\n\ncisplatin, 240-400; oxaliplatin, 400-800'}, {'id': 'OG004', 'title': 'Vinca Alkaloids Group: Multivitamin (MV) Arm', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n\nRanges of cumulative doses (in mg/m2) are:\n\nvincristine, 8-16; vinorelbine, 360-480'}, {'id': 'OG005', 'title': 'Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm', 'description': 'Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nRanges of cumulative doses (in mg/m2) are:\n\nvincristine, 8-16; vinorelbine, 360-480'}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '8.71', 'spread': '6.5', 'groupId': 'OG002'}, {'value': '7.05', 'spread': '6.55', 'groupId': 'OG003'}, {'value': '17.5', 'spread': '5.36', 'groupId': 'OG004'}, {'value': '9.22', 'spread': '10.22', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 92 \\& 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 57 \\& 65 patients, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemotherapy and completed the FACT-Tax questionnaire at cycle 4, and the analysis is presented here. The same applies to 28 \\& 21 patients in Group 2 (Heavy Metals) and 6 \\& 9 patients in Group 3 (Vinca)'}, {'type': 'PRIMARY', 'title': 'Change in Neurotoxicity Assessment Between Cycle 4 and Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Taxane Group: Multivitamin (MV) Arm', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n\nRanges of cumulative doses (in mg/m2) are:\n\npaclitaxel, 700-960; docetaxel, abraxane, 1200-1800'}, {'id': 'OG001', 'title': 'Taxane Group: MV + Vitamin B12 + Vitamin B6', 'description': 'Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nRanges of cumulative doses (in mg/m2) are:\n\npaclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800'}, {'id': 'OG002', 'title': 'Heavy Metals Group: Multivitamin (MV) Arm', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n\nRanges of cumulative doses (in mg/m2) are:\n\ncisplatin, 240-400; oxaliplatin, 400-800'}, {'id': 'OG003', 'title': 'Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm', 'description': 'Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nRanges of cumulative doses (in mg/m2) are:\n\ncisplatin, 240-400; oxaliplatin, 400-800'}, {'id': 'OG004', 'title': 'Vinca Alkaloids Group: Multivitamin (MV) Arm', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n\nRanges of cumulative doses (in mg/m2) are:\n\nvincristine, 8-16; vinorelbine, 360-480'}, {'id': 'OG005', 'title': 'Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm', 'description': 'Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nRanges of cumulative doses (in mg/m2) are:\n\nvincristine, 8-16; vinorelbine, 360-480'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '7.1', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '5.7', 'groupId': 'OG003'}, {'value': '11.8', 'spread': '4.7', 'groupId': 'OG004'}, {'value': '7', 'spread': '9.2', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 92 \\& 97 patients in the Multivitamin (MV) and MV + Vit.B12 + VitB6 arms, 54 \\& 62, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemo and the FACT-Tax questionnaire at baseline and cycle 4; analysis is presented here. The same applies to 28 \\& 20 patients in Group 2 (Heavy Metals) and 5 \\& 9 patients in Group 3 (Vinca)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Multivitamin (MV)', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)'}, {'id': 'FG001', 'title': 'Multivitamin + Vitamin B12 + Vitamin B6', 'description': 'Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nCumulative doses (in mg/m2) are:\n\npaclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '162'}]}, {'type': 'Group 1 (Heavy Metals)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'Group 2 (Vinca Alkaloids)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Group 3 (Taxanes)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited between July, 2006, and September, 2013, at participating cancer clinics across the state of New Mexico'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Multivitamin (MV)', 'description': 'Multivitamin only\n\nMultivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.\n\n1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)'}, {'id': 'BG001', 'title': 'Multivitamin + Vitamin B12 + Vitamin B6', 'description': 'Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections\n\nMultivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.\n\nCumulative doses (in mg/m2) are:\n\npaclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '83'}, {'value': '54.5', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '80'}, {'value': '55', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-27', 'studyFirstSubmitDate': '2008-04-14', 'resultsFirstSubmitDate': '2015-06-18', 'studyFirstSubmitQcDate': '2008-04-15', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-16', 'studyFirstPostDateStruct': {'date': '2008-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurotoxicity Assessment at Baseline', 'timeFrame': 'At study start; prior to treatment (week 0)', 'description': 'Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported.'}, {'measure': 'Neurotoxicity Assessment at Cycle 2', 'timeFrame': '2 weeks', 'description': 'Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported.'}, {'measure': 'Neurotoxicity Assessment at Cycle 4', 'timeFrame': '4 weeks', 'description': 'Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported.'}, {'measure': 'Change in Neurotoxicity Assessment Between Cycle 4 and Baseline', 'timeFrame': '4 weeks', 'description': 'Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vitamin B-12', 'Vitamin B-6', 'Chemotherapy-Induced Neuropathy', 'Taxanes', 'Vinca alkaloid', 'Heavy metals', 'Neuropathy', 'Nerve pain'], 'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nmcca.org', 'label': 'New Mexico Cancer Care Alliance'}, {'url': 'http://www.cancer.unm.edu', 'label': 'University of New Mexico Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Many types of chemotherapy may cause nerve damage as a side effect. This neurotoxicity can manifest as peripheral sensory neuropathy (characterized by numbness, tingling, or pain). The goal of this study is to determine the efficacy of the combination of vitamin B6 and B12 in preventing chemotherapy induced neuropathy.', 'detailedDescription': 'Neuropathy can be a significant side effect of chemotherapy using platinum compounds, taxanes, and vinca alkaloids. There is clinical and preclinical data that vitamin B6 and B12 may alleviate neuropathy in experimentally induced neuropathy in animal models, or clinical neuropathy such as diabetic neuropathy. This is a randomized phase III study of the use of multivitamins with or without vitamin B6 and B12 to prevent or relieve neuropathic toxicity from chemotherapy in patients receiving chemotherapy. Patients will be stratified by type of chemotherapy agent (3 groups), presence or absence of neuropathy at baseline, and randomized to receive placebo or vitamin B6/B12 supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients, 18 years of age or older, with a cancer treated with any of the following drugs are eligible:\n\n * Taxanes, vinca alkaloid analogs, heavy metals.\n * Each patient will be allocated to the following 3 groups:\n\n * Group 1 (Heavy metals): Patients treated with cisplatin (\\>25 mg/m2/week dose intensity) or oxaliplatin\n * Group 2 (Taxane): Patients treated with paclitaxel, docetaxel or abraxane\n * Group 3 (Vinca alkaloids): Patients treated with vincristine and vinorelbine.\n2. Patients must have a life expectancy of at least 24 weeks.\n3. Patients must have a Zubrod performance status of 0-2.\n4. Patients must sign an informed consent.\n5. Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.\n\nExclusion Criteria:\n\n1. Patients with symptomatic brain metastases are excluded from this study.\n2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.\n3. Patients may receive no other concurrent complementary medicines during this study.\n4. Patients with neuropathy induced diabetes are not eligible for this study\n5. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.'}, 'identificationModule': {'nctId': 'NCT00659269', 'briefTitle': 'A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'New Mexico Cancer Research Alliance'}, 'officialTitle': 'A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients.', 'orgStudyIdInfo': {'id': 'INST 0553C'}, 'secondaryIdInfos': [{'id': 'NCI-2012-00946', 'type': 'REGISTRY', 'domain': 'National Cancer Institute CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Multivitamin (MV)', 'description': '1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)', 'interventionNames': ['Dietary Supplement: Multivitamin (MV)', 'Drug: Chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Multivitamin + Vitamin B12 + Vitamin B6', 'description': '1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).\n\nThe patient will also take the following, starting on the first day of chemotherapy:\n\n1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)\n2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.', 'interventionNames': ['Dietary Supplement: Multivitamin + Vitamin B12 + Vitamin B6', 'Drug: Chemotherapy']}], 'interventions': [{'name': 'Multivitamin (MV)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.', 'armGroupLabels': ['Multivitamin (MV)']}, {'name': 'Multivitamin + Vitamin B12 + Vitamin B6', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Multivitamin (containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12), plus Vitamin B6 tablets and Vitamin B12 injections', 'armGroupLabels': ['Multivitamin + Vitamin B12 + Vitamin B6']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'otherNames': ['Cisplatin (Platinol, Platinol-AQ)', 'Oxaliplatin (Eloxatin)', 'Paclitaxel (Taxol, Abraxane)', 'Docetaxel (Taxotere)', 'Vincristine (Oncovin)', 'Vinorelbine tartrate (Navelbine)'], 'description': 'Patients are treated per standard of care according to the choice of the treating physician with heavy metals (cisplatin, oxaliplatin), taxanes (paclitaxel, docetaxel), or vinca alkaloids (vincristine, vinorelbine)\n\nRanges of cumulative doses (in mg/m2) are:\n\npaclitaxel, 700-960; docetaxel, 240-400; vincristine, 8-16; vinorelbine, 360-480; cisplatin, 240-400; oxaliplatin, 400-800; abraxane, 1200-1800', 'armGroupLabels': ['Multivitamin (MV)', 'Multivitamin + Vitamin B12 + Vitamin B6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Cancer Center @ Lovelace Medical Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Hematology Oncology Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87110', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Cancer Center at Presbyterian Hospital', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87505', 'city': 'Santa Fe', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico Cancer Care Associates', 'geoPoint': {'lat': 35.68698, 'lon': -105.9378}}], 'overallOfficials': [{'name': 'Zoneddy Dayao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNM Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Mexico Cancer Research Alliance', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}