Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-13 @ 12:35 PM
Study NCT ID:
NCT02590367
Status:
UNKNOWN
Last Update Posted:
2015-12-02
First Post:
2015-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimate the Efficacy of HD6610 Granule for Oxaliplatin-induced Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C410216', 'term': 'Folfox protocol'}, {'id': 'C519688', 'term': 'XELOX'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2015-09-14', 'studyFirstSubmitQcDate': '2015-10-27', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of patients with different degree of peripheral nerve toxicity.', 'timeFrame': 'Through study completion, an average of 1 year.'}], 'secondaryOutcomes': [{'measure': 'EORTC（European Organization for Research and Treatment of Cancer） quality of life score', 'timeFrame': 'Through study completion, an average of 1 year.'}, {'measure': 'KPS（ Karnofsky Performance Status Scale） score', 'timeFrame': 'Through study completion, an average of 1 year.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['oxaliplatin-induced peripheral neuropathy', 'HD6610 granule', 'colorectal cancer'], 'conditions': ['Peripheral Neuropathy']}, 'referencesModule': {'references': [{'pmid': '25833669', 'type': 'BACKGROUND', 'citation': 'Balayssac D, Ferrier J, Pereira B, Gillet B, Petorin C, Vein J, Libert F, Eschalier A, Pezet D. Prevention of oxaliplatin-induced peripheral neuropathy by a polyamine-reduced diet-NEUROXAPOL: protocol of a prospective, randomised, controlled, single-blind and monocentric trial. BMJ Open. 2015 Apr 1;5(4):e007479. doi: 10.1136/bmjopen-2014-007479.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the usefulness and safety of HD6610 granule for oxaliplatin-induced peripheral neuropathy. The investigators examined the efficacy and safety of the treatment algorithm for 64 patients with colorectal cancer by evaluating the side effects and degree of improvement of subjective symptoms.', 'detailedDescription': "Oxaliplatin is the third generation platinum-based cytotoxic agent, widely used in colorectal cancer, in metastatic disease and in the adjuvant setting . Moreover, oxaliplatin is being used as an alternative option to cisplatin in various cancers, such as ovarian, gastric. Oxaliplatin-induced peripheral neuropathy is characterised by acute and transient cold hyperaesthesia in the hours and days following oxaliplatin infusion (\\>90% of patients), but also by retarded chronic neuropathy due to the repetition of chemotherapy cycles (30-50% of patients). Oxaliplatin-induced peripheral neuropathy impairs the health-related quality of life (HRQOL) of patients and no preventive or curative strategies have as yet proven effective so far. Animal experiment show that HD6610 granule can relieve mouse's peripheral neuropathy induced by oxaliplatin. In clinical practice, the investigators also find that HD6610 granule can relieve patient's oxaliplatin-induced peripheral neuropathy in the treatment of chemotherapy. So the investigators design this randomized, parallel-group, double-blind, placebo-controlled, multicenter clinical study to estimate the efficacy and safety of HD6610 granule for oxaliplatin-induced peripheral neuropathy in colorectal cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All cases have been diagnosed with colorectal cancer by pathology;\n2. Patients who received no chemotherapy before should receive oxaliplatin-based chemotherapy(FOLFOX4,FOLFOX6,XELOX) ;\n3. Patients of 18-70 years old have no serious heart,liver,kidney and hematopoietic disfunction,life expectancy of over 3 months and KPS more than 60;\n4. Patients with no positive sign in neurological examination,and no drug allergy history or diabetes;\n5. Volunteered to participate and signed informed consent,patients can not receive radiotherapy,acupuncture and moxibustion or other treatment during the experiment.\n\nExclusion Criteria:\n\n1. Not accordant with the inclusion criteria;\n2. Patients who have used herbal within 4 weeks before registration;\n3. Patients who have serious heart,liver,kidney and hematopoietic disfunction;\n4. Patients of central nervous system disease;\n5. Patients of cervical spondylopathy,lumbar disc protrusion,diabetes and uremia which can potentially cause peripheral neuropathy;\n6. Nerve compression caused by tumor metastasis or peripheral neuropathy caused by electrolyte disturbances,diabetes,alcohol disease and other disorder;\n7. Long-time using of thiazide diuretic and foxglove;\n8. Patients of poisoning,infection and radiotherapy which induced peripheral neuropathy or receiving medicine which can cause peripheral neuropathy;\n9. Patients who can hardly take Chinese Medicine with severe diarrhea,vomiting or intestinal obstruction ;\n10. Uncontrolled psychosis;\n11. Women of pregnancy ,preparing pregnant, or lactation;\n12. Alcohol and drug abuse;\n13. Allergic constitution or allergy to experiment drugs.'}, 'identificationModule': {'nctId': 'NCT02590367', 'briefTitle': 'Estimate the Efficacy of HD6610 Granule for Oxaliplatin-induced Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Jiangsu Province Hospital of Traditional Chinese Medicine'}, 'officialTitle': 'Huo JieGe, Doctor of Medicine,Professor of Medicine,Professor of Medical Science.', 'orgStudyIdInfo': {'id': 'JiangsuPHTCM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FOLFOX regimen&HD6610 Granule', 'description': 'Patients in this group will be given conventional oxaliplatin based chemotherapy recommended by treatment guidelines for colorectal cancer, and the HD6610 Granule will be given 2 times a day.', 'interventionNames': ['Drug: FOLFOX regimen', 'Drug: HD6610 Granule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'FOLFOX regimen&HD6610 Granule placebo', 'description': 'Patients in this group will be given conventional oxaliplatin based chemotherapy recommended by treatment guidelines for colorectal cancer, and the placebo HD6610 Granule', 'interventionNames': ['Drug: FOLFOX regimen', 'Drug: HD6610 Granule placebo']}], 'interventions': [{'name': 'FOLFOX regimen', 'type': 'DRUG', 'otherNames': ['XELOX'], 'description': 'FOLFOX regimens are combination therapy of oxaliplatin (85 mg/m\\^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m\\^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m\\^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (different dose like FOLFOX4/FOLFOX6) via ambulatory pump administered for a period of 46 to 48 hours.\n\nXELOX is a combination therapy of Oxaliplatin 130mg/ m\\^2 d1 Intravenous infusion, every 3 weeks. and Capecitabine 1000mg/m\\^2 bid, days 1-14, every 3 weeks.', 'armGroupLabels': ['FOLFOX regimen&HD6610 Granule', 'FOLFOX regimen&HD6610 Granule placebo']}, {'name': 'HD6610 Granule', 'type': 'DRUG', 'description': 'the HD6610 Granule will be given 2 times a day.', 'armGroupLabels': ['FOLFOX regimen&HD6610 Granule']}, {'name': 'HD6610 Granule placebo', 'type': 'DRUG', 'description': 'the HD6610 Granule placebo will be given 2 times a day.', 'armGroupLabels': ['FOLFOX regimen&HD6610 Granule placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210028', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huo Jie Ge, M.D.', 'role': 'CONTACT', 'email': 'hjg16688@126.com', 'phone': '+86 02585637121'}], 'facility': 'Jiangsu Province Hospital of Integrated Chinese and Western Medicine', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Huo JieGe, M.D.', 'role': 'CONTACT', 'email': 'hjg16688@126.com', 'phone': '+86 02585637121'}], 'overallOfficials': [{'name': 'Huo JieGe, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jiangsu Province Hospital of Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Province Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Huo JieGe, Doctor of Medicine,Professor of Medicine,Professor of Medical Science.', 'investigatorFullName': 'JieGe Huo', 'investigatorAffiliation': 'Jiangsu Province Hospital of Traditional Chinese Medicine'}}}}