Clinical trial NCT04770402: Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients
Official title: Acupuncture for Chemo-Induced Peripheral Neuropathy (CIPN) in Multiple Myeloma (MM) Patients- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Neuropathy
Multiple Myeloma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
First posted: 2021-02-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Age ≥ 18 years at the time of consent
3. Subject has diagnosis of Multiple Myeloma (any stage) per Investigator
4. Currently being treated with bortezomib or bortezomib-combination chemotherapy
5. ECOG Performance status of 0-3
6. Life expectancy of ≥ 12 weeks
7. Chemotherapy-Induced Peripheral Neuropathy score of ≥ 2
8. No planned hospital admission in the next 10 weeks
9. 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:

1. Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator
2. Subjects with neuropathy pain as a result of spinal injury or vertebral compression fractures
3. Subjects with needle phobia
4. Previous diagnosis of amyloidosis or POEMS syndrome
5. Local infection at or near the planned acupuncture sites (see Appendix A)
6. Subjects with metastatic involvement of the nervous system/active central nervous system disease
7. Plan to receive Healing Touch or Oncology Massage during study
8. Have received acupuncture within 30 days prior to enrollment

Primary outcomes:
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.
Secondary outcomes:
measure: Specific Features of Chemotherapy-Induced Peripheral Neuropathy From FACT-GOG-NTX
timeFrame: 10 weeks
measure: Nausea - FACT-GOG-NTX
timeFrame: approx. 10 weeks
measure: Sadness- FACT-GOG-NTX
timeFrame: approx. 10 weeks
measure: Nervousness- FACT-GOG-NTX
timeFrame: approx. 10 weeks
measure: Sleep Quality- FACT-GOG-NTX
timeFrame: approx. 10 weeks
measure: Lack of Energy- FACT-GOG-NTX
timeFrame: approx. 10 weeks
measure: Pain- FACT-GOG-NTX
timeFrame: approx. 10 weeks
measure: Constipation
timeFrame: approx. 10 weeks
measure: Dizziness
timeFrame: approx. 10 weeks
measure: Dry Mouth
timeFrame: approx. 10 weeks
measure: General Health - CDC-HRQOL
timeFrame: approx. 10 weeks
Other outcomes:
measure: Adverse Events of Special Interest
timeFrame: approx. 10 weeks
measure: Opioid Use
timeFrame: approx. 10 weeks
measure: Acupuncture Administration
timeFrame: approx. 10 weeks
measure: Acupuncture Expectancy
timeFrame: approx 10 weeks
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Shamille Hariharan, MD
role: PRINCIPAL_INVESTIGATOR
References: