Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients

NCT ID: NCT04770402

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2023-04-06

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Acupuncture

Subjects on this arm will receive 12 sessions of acupuncture over approximately 10 weeks, along with continued standard treatment by their physician.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

12 acupuncture sessions over 10 weeks

Standard of Care

Subjects on this arm will not receive acupuncture, but will continue to be followed by their physician with standard treatment for their neuropathy.

Group Type: ACTIVE_COMPARATOR

Standard of Care CIPN management

Intervention Type: OTHER

Investigator directed standard of care management of CIPN

Interventions

Acupuncture

12 acupuncture sessions over 10 weeks

Intervention Type: OTHER

Standard of Care CIPN management

Investigator directed standard of care management of CIPN

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atrium Health Levine Cancer Institute

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shamille Hariharan, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Levine Cancer Institute

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

00049444

Identifier Type: OTHER

Identifier Source: secondary_id

LCI-SUPP-MYE-ACUP-001

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00081364

Identifier Type: -

Identifier Source: org_study_id