Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT04770402
Status:
TERMINATED
Last Update Posted:
2025-01-27
First Post:
2021-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'james.symanowski@atriumhealth.org', 'phone': '9804422371', 'title': 'Chair of Biostatistics Department', 'organization': 'Atrium Health Levine Cancer'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination due to low accrual leading to small number of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'AESIs were collected for approximately 10 weeks for the duration of the acupuncture treatment (for those on the intervention arm) and collected through 30 days after last acupuncture session. Serious adverse events and all-cause mortality were monitored and collected for both arms throughout the study, approximately 10 weeks.', 'description': 'Only All-Cause Mortality, Serious Adverse Events, and Adverse Events of Special Interest (AESI) were collected for this study. All-cause mortality and Serious Adverse Events were collected for both arms as defined in the clinicaltrials.gov definition. AESIs were collected only for subjects on the intervention arm, including bleeding, bruising, skin infection, edema, dry skin, urticaria, pruritus, rash, pain or flushing at the acupuncture site, dizziness, syncope, fatigue, or hyperhidrosis.', 'eventGroups': [{'id': 'EG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy Who Received Acupuncture vs Standard of Care Management.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'title': 'Experienced at least a 2 point improvement in neuropathy between baseline and Week 10', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Did not experience at least a 2 point improvement in neuropathy between baseline and Week 10', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 10 weeks, from baseline measure to 10 week (+/- 1 week) measure.', 'description': 'Neuropathy will be subject reported using an 11-point scale from 0-no neuropathy to 10-worst possible neuropathy. The outcome will be measured as a binary variable indicating whether or not a subject experienced at least a 2-point improvement in neuropathy between the baseline score and the score obtained at Week 10 +/- 1 week.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.'}, {'type': 'SECONDARY', 'title': 'Specific Features of Chemotherapy-Induced Peripheral Neuropathy From FACT-GOG-NTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '27.0'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '23.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '10 weeks', 'description': 'Specific features of CIPN assessed through the subscale from FACT-GOG-NTX will be determined for each subject as a composite measure, which is calculated as the sum of the responses to the subscale questions. For subjects who complete all 12 subscale questions, the composite score will range from 0 to 48. Higher scores mean worse outcome', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.'}, {'type': 'SECONDARY', 'title': 'Nausea - FACT-GOG-NTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'A little bit', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Somewhat', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Quite a bit', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very much', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approx. 10 weeks', 'description': "Nausea will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP2 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have nausea.'", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.'}, {'type': 'SECONDARY', 'title': 'Sadness- FACT-GOG-NTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'A little bit', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Somewhat', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Quite a bit', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very much', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approx. 10 weeks', 'description': "Sadness will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GE1 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I feel sad'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.'}, {'type': 'SECONDARY', 'title': 'Nervousness- FACT-GOG-NTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'A little bit', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Somewhat', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Quite a bit', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very much', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approx. 10 weeks', 'description': "Nervousness will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GE4 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I feel nervous.'", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.'}, {'type': 'SECONDARY', 'title': 'Sleep Quality- FACT-GOG-NTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'A little bit', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Somewhat', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Quite a bit', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very much', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approx. 10 weeks', 'description': "Sleep quality will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GF5 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I am sleeping well.'", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.'}, {'type': 'SECONDARY', 'title': 'Lack of Energy- FACT-GOG-NTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'A little bit', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Somewhat', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Quite a bit', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very much', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approx. 10 weeks', 'description': "Lack of energy will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP1 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have a lack of energy.'", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.'}, {'type': 'SECONDARY', 'title': 'Pain- FACT-GOG-NTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very little', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Somewhat', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Quite a bit', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Very much', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approx. 10 weeks', 'description': "Pain will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP4 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have pain.'", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.'}, {'type': 'SECONDARY', 'title': 'Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'A little bit', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Somewhat', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Quite a bit', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very much', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approx. 10 weeks', 'description': "Constipation will be determined for each subject as a 5-level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have constipation.'", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.'}, {'type': 'SECONDARY', 'title': 'Dizziness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'A little bit', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Somewhat', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Quite a bit', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very much', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approx. 10 weeks', 'description': "Dizziness will be determined for each subject as a 5- level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. This item is to rate the statement 'I have dizziness'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.'}, {'type': 'SECONDARY', 'title': 'Dry Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'title': 'Not at all', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'A little bit', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Somewhat', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Quite a bit', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very much', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approx. 10 weeks', 'description': "Dry mouth will be determined for each subject as a 5- level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. This item is to rate the statement 'I have dry mouth.'", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.'}, {'type': 'SECONDARY', 'title': 'General Health - CDC-HRQOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'title': 'Excellent', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Very good', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Good', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Fair', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approx. 10 weeks', 'description': 'General Health assessed through CDC-HRQOL Question 1 will be calculated for each subject as a 5- level ordinal variable from Poor to Excellent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Events of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approx. 10 weeks', 'description': 'Adverse Events of Special Interest (AESI) will be determined for each subject as binary variables indicating whether or not they experienced a protocol defined AESI, including bleeding, bruising, skin infection, edema, dry skin, urticaria, pruritus, rash, pain or flushing at the acupuncture site, or dizziness, syncope, fatigue, or hyperhidrosis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants on the acupuncture arm'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Opioid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '82.5', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '150.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'approx. 10 weeks', 'description': 'Opioid use will be calculated for each subject as a quantitative value assessed through Morphine Equivalent Daily Dose (MEDD).', 'unitOfMeasure': 'morphine milligram equivalents per day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants receiving acupuncture or standard of care'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acupuncture Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'approx. 10 weeks', 'description': 'Acupuncture administration will be defined for each subject on the acupuncture arm as the number of attended acupuncture sessions from 0 to 12.', 'unitOfMeasure': 'number of acupuncture sessions', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants randomized to the acupuncture arm'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acupuncture Expectancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: investigator directed standard of care management of CIPN'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'approx 10 weeks', 'description': 'The acupuncture expectancy score will be captured quantitatively for each subject as a composite score ranging from 4 to 20. Higher scores indicate higher expectancy of acupuncture.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants randomized to the acupuncture arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acupuncture', 'description': 'Acupuncture: 12 acupuncture sessions over 10 weeks'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Standard of Care CIPN management: Investigator directed standard of care management of CIPN'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'groupId': 'BG000', 'lowerLimit': '58.5', 'upperLimit': '69.5'}, {'value': '58.0', 'groupId': 'BG001', 'lowerLimit': '56.0', 'upperLimit': '68.5'}, {'value': '62.0', 'groupId': 'BG002', 'lowerLimit': '56.0', 'upperLimit': '69.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Chemotherapy-Induced Peripheral Neuropathy Score', 'classes': [{'categories': [{'title': '4', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '6', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '7', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '8', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '9', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Neuropathy is subject reported using an 11-point scale from 0-no neuropathy to 10-worst possible neuropathy.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-21', 'size': 1018136, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-28T11:48', 'hasProtocol': True}, {'date': '2023-04-13', 'size': 8411174, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-22T10:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2021-02-22', 'resultsFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-12', 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events of Special Interest', 'timeFrame': 'approx. 10 weeks', 'description': 'Adverse Events of Special Interest (AESI) will be determined for each subject as binary variables indicating whether or not they experienced a protocol defined AESI, including bleeding, bruising, skin infection, edema, dry skin, urticaria, pruritus, rash, pain or flushing at the acupuncture site, or dizziness, syncope, fatigue, or hyperhidrosis.'}, {'measure': 'Opioid Use', 'timeFrame': 'approx. 10 weeks', 'description': 'Opioid use will be calculated for each subject as a quantitative value assessed through Morphine Equivalent Daily Dose (MEDD).'}, {'measure': 'Acupuncture Administration', 'timeFrame': 'approx. 10 weeks', 'description': 'Acupuncture administration will be defined for each subject on the acupuncture arm as the number of attended acupuncture sessions from 0 to 12.'}, {'measure': 'Acupuncture Expectancy', 'timeFrame': 'approx 10 weeks', 'description': 'The acupuncture expectancy score will be captured quantitatively for each subject as a composite score ranging from 4 to 20. Higher scores indicate higher expectancy of acupuncture.'}], 'primaryOutcomes': [{'measure': 'Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy Who Received Acupuncture vs Standard of Care Management.', 'timeFrame': 'Approximately 10 weeks, from baseline measure to 10 week (+/- 1 week) measure.', 'description': 'Neuropathy will be subject reported using an 11-point scale from 0-no neuropathy to 10-worst possible neuropathy. The outcome will be measured as a binary variable indicating whether or not a subject experienced at least a 2-point improvement in neuropathy between the baseline score and the score obtained at Week 10 +/- 1 week.'}], 'secondaryOutcomes': [{'measure': 'Specific Features of Chemotherapy-Induced Peripheral Neuropathy From FACT-GOG-NTX', 'timeFrame': '10 weeks', 'description': 'Specific features of CIPN assessed through the subscale from FACT-GOG-NTX will be determined for each subject as a composite measure, which is calculated as the sum of the responses to the subscale questions. For subjects who complete all 12 subscale questions, the composite score will range from 0 to 48. Higher scores mean worse outcome'}, {'measure': 'Nausea - FACT-GOG-NTX', 'timeFrame': 'approx. 10 weeks', 'description': "Nausea will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP2 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have nausea.'"}, {'measure': 'Sadness- FACT-GOG-NTX', 'timeFrame': 'approx. 10 weeks', 'description': "Sadness will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GE1 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I feel sad'."}, {'measure': 'Nervousness- FACT-GOG-NTX', 'timeFrame': 'approx. 10 weeks', 'description': "Nervousness will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GE4 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I feel nervous.'"}, {'measure': 'Sleep Quality- FACT-GOG-NTX', 'timeFrame': 'approx. 10 weeks', 'description': "Sleep quality will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GF5 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I am sleeping well.'"}, {'measure': 'Lack of Energy- FACT-GOG-NTX', 'timeFrame': 'approx. 10 weeks', 'description': "Lack of energy will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP1 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have a lack of energy.'"}, {'measure': 'Pain- FACT-GOG-NTX', 'timeFrame': 'approx. 10 weeks', 'description': "Pain will be determined for each subject as 5 level ordinal variable from 0 = not at all to 4 = very much through question GP4 on the FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have pain.'"}, {'measure': 'Constipation', 'timeFrame': 'approx. 10 weeks', 'description': "Constipation will be determined for each subject as a 5-level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. The item is to rate the statement 'I have constipation.'"}, {'measure': 'Dizziness', 'timeFrame': 'approx. 10 weeks', 'description': "Dizziness will be determined for each subject as a 5- level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. This item is to rate the statement 'I have dizziness'."}, {'measure': 'Dry Mouth', 'timeFrame': 'approx. 10 weeks', 'description': "Dry mouth will be determined for each subject as a 5- level ordinal variable from 0 = not at all to 4 = very much through additional question amended to FACT-GOG-NTX subject-reported assessment. This item is to rate the statement 'I have dry mouth.'"}, {'measure': 'General Health - CDC-HRQOL', 'timeFrame': 'approx. 10 weeks', 'description': 'General Health assessed through CDC-HRQOL Question 1 will be calculated for each subject as a 5- level ordinal variable from Poor to Excellent.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuropathy', 'Multiple Myeloma'], 'conditions': ['Chemotherapy-induced Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': 'This randomized, controlled trial is designed to evaluate the effect of acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN), other symptoms, and potential opioid and concomitant medication sparing effects in comparison to standard of care management in Multiple Myeloma subjects.', 'detailedDescription': "This study aims to strengthen the care of persons with Multiple Myeloma by improving quality of life (QOL) and ability to perform daily activities through reduced Chemotherapy-Induced Peripheral Neuropathy (CIPN) symptoms. CIPN debilitates and erodes QOL by preventing individuals from pursuing their normal activities of daily living.\n\nThe features of CIPN, including physical, social/family, emotional, functional, and specific CIPN symptoms, will be measured with the validated FACT-GOG-NTX. This project brings necessary attention and scientific inquiry to supportive cancer care, which is sometimes de-prioritized behind disease treatment. The potential for nonpharmacologic acupuncture to reduce CIPN and other symptoms with minimal side effects has beneficial implications for disease treatment. Patients with controlled symptoms are better able to tolerate life-prolonging treatment and avoid chemotherapy dose reductions which result from neurotoxic side effects of chemotherapy.\n\nSubjects who consent and are determined to be eligible will be randomized to receive either acupuncture treatment or standard of care treatment for their CIPN. Subjects' socio-demographics, medical history, opioid and concomitant medication intake information will be collected. Subjects who are randomized to the acupuncture treatment arm will receive 12 sessions of acupuncture over approximately 10 weeks. Subjects randomized to standard of care will continue with standard of care therapy per their physician for treatment of their CIPN. All subjects will complete questionnaires at Baseline, mid-point, and endpoint. Responses to questionnaires will then be analyzed towards answering the study's objectives."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent\n3. Subject has diagnosis of Multiple Myeloma (any stage) per Investigator\n4. Currently being treated with bortezomib or bortezomib-combination chemotherapy\n5. ECOG Performance status of 0-3\n6. Life expectancy of ≥ 12 weeks\n7. Chemotherapy-Induced Peripheral Neuropathy score of ≥ 2\n8. No planned hospital admission in the next 10 weeks\n9. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study\n\nExclusion Criteria:\n\n1. Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator\n2. Subjects with neuropathy pain as a result of spinal injury or vertebral compression fractures\n3. Subjects with needle phobia\n4. Previous diagnosis of amyloidosis or POEMS syndrome\n5. Local infection at or near the planned acupuncture sites (see Appendix A)\n6. Subjects with metastatic involvement of the nervous system/active central nervous system disease\n7. Plan to receive Healing Touch or Oncology Massage during study\n8. Have received acupuncture within 30 days prior to enrollment'}, 'identificationModule': {'nctId': 'NCT04770402', 'briefTitle': 'Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Acupuncture for Chemo-Induced Peripheral Neuropathy (CIPN) in Multiple Myeloma (MM) Patients- A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB00081364'}, 'secondaryIdInfos': [{'id': '00049444', 'type': 'OTHER', 'domain': 'Advarra IRB'}, {'id': 'LCI-SUPP-MYE-ACUP-001', 'type': 'OTHER', 'domain': 'Atrium Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'Subjects on this arm will receive 12 sessions of acupuncture over approximately 10 weeks, along with continued standard treatment by their physician.', 'interventionNames': ['Other: Acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Subjects on this arm will not receive acupuncture, but will continue to be followed by their physician with standard treatment for their neuropathy.', 'interventionNames': ['Other: Standard of Care CIPN management']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': '12 acupuncture sessions over 10 weeks', 'armGroupLabels': ['Acupuncture']}, {'name': 'Standard of Care CIPN management', 'type': 'OTHER', 'description': 'Investigator directed standard of care management of CIPN', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Shamille Hariharan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Atrium Health Levine Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}