Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The 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. Subjects 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.

Official Title
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Acupuncture for Chemo-Induced Peripheral Neuropathy (CIPN) in Multiple Myeloma (MM) Patients- A Randomized Controlled Trial

Conditions
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Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Other: Acupuncture
* Other: Standard of Care CIPN management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Age ≥ 18 years at the time of consent Subject has diagnosis of Multiple Myeloma (any stage) per Investigator Currently being treated with bortezomib or bortezomib-combination chemotherapy ECOG Performance status of 0-3 Life expectancy of ≥ 12 weeks Chemotherapy-Induced Peripheral Neuropathy score of ≥ 2 No planned hospital admission in the next 10 weeks As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study Exclusion Criteria: Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator Subjects with neuropathy pain as a result of spinal injury or vertebral compression fractures Subjects with needle phobia Previous diagnosis of amyloidosis or POEMS syndrome Local infection at or near the planned acupuncture sites (see Appendix A) Subjects with metastatic involvement of the nervous system/active central nervous system disease Plan to receive Healing Touch or Oncology Massage during study Have received acupuncture within 30 days prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br> | Other: Acupuncture<br>* 12 acupuncture sessions over 10 weeks<br>|
| Active Comparator: Standard of Care<br> | Other: Standard of Care CIPN management<br>* Investigator directed standard of care management of CIPN<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the change of neuropathy in actively treated multiple myeloma subjects diagnosed with CIPN who received acupuncture vs standard of care management. | 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. | approx. 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Specific features of CIPN - Nausea | 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 | approx. 10 weeks | 
| Assess Specific features of CIPN - Sadness | 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. | approx. 10 weeks | 
| Assess Specific features of CIPN - Nervousness | 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. | approx. 10 weeks | 
| Assess Specific features of CIPN - Sleep quality | 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. | approx. 10 weeks | 
| Assess Specific features of CIPN - Lack of energy | 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. | approx. 10 weeks | 
| Assess Specific features of CIPN - Pain | 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. | approx. 10 weeks | 
| Assess Specific features of CIPN - Constipation | 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. | approx. 10 weeks | 
| Assess Specific features of CIPN - Dizziness | 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. | approx. 10 weeks | 
| Assess Specific features of CIPN - Dry Mouth | 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. | approx. 10 weeks | 
| Assess Quality of Life | Quality of life will be determined quantitatively using CDC HRQoL-4 questionnaire indicating number of days QOL has been impacted. | approx. 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathy, Multiple Myeloma