Status:
TERMINATED
Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Atrium Health Levine Cancer Institute
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 medicatio...
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 Neuro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04770402
Start Date
September 15 2021
End Date
April 6 2023
Last Update
January 27 2025
Active Locations (1)
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1
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204