Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients

Not Applicable

Terminated

Conditions: Chemotherapy-induced Peripheral Neuropathy

Interventions: Other: Standard of Care CIPN management
Other: Acupuncture

Registration Number: NCT04770402

Lead Sponsor: Wake Forest University Health Sciences

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care CIPN management	-
Acupuncture	Acupuncture	-

Primary Outcome Measures

Name	Time	Method
Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy Who Received Acupuncture vs Standard of Care Management.	Approximately 10 weeks, from baseline measure to 10 week (+/- 1 week) measure.	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.

Secondary Outcome Measures

Name	Time	Method
Nervousness- FACT-GOG-NTX	approx. 10 weeks	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.'
Specific Features of Chemotherapy-Induced Peripheral Neuropathy From FACT-GOG-NTX	10 weeks	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
Nausea - FACT-GOG-NTX	approx. 10 weeks	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.'
Sadness- FACT-GOG-NTX	approx. 10 weeks	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'.
Sleep Quality- FACT-GOG-NTX	approx. 10 weeks	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.'
Lack of Energy- FACT-GOG-NTX	approx. 10 weeks	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.'
Pain- FACT-GOG-NTX	approx. 10 weeks	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.'
Constipation	approx. 10 weeks	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.'
Dizziness	approx. 10 weeks	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'.
Dry Mouth	approx. 10 weeks	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.'
General Health - CDC-HRQOL	approx. 10 weeks	General Health assessed through CDC-HRQOL Question 1 will be calculated for each subject as a 5- level ordinal variable from Poor to Excellent.