Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients

NCT04770402 | Terminated Results DMC

• 3 other identifiers: IRB0008136400049444LCI-SUPP-MYE-ACUP-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Neuropathy; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy 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.

  Approximately 10 weeks, from baseline measure to 10 week (+/- 1 week) measure.

Secondary Outcomes (11)

• Specific Features of Chemotherapy-Induced Peripheral Neuropathy From FACT-GOG-NTX

  10 weeks

• Nausea - FACT-GOG-NTX

  approx. 10 weeks

• Sadness- FACT-GOG-NTX

  approx. 10 weeks

• Nervousness- FACT-GOG-NTX

  approx. 10 weeks

• Sleep Quality- FACT-GOG-NTX

  approx. 10 weeks

Other Outcomes (4)

• Adverse Events of Special Interest

  approx. 10 weeks

• Opioid Use

  approx. 10 weeks

• Acupuncture Administration

  approx. 10 weeks

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Other: Acupuncture

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care CIPN management

Interventions

Acupuncture OTHER

12 acupuncture sessions over 10 weeks

Acupuncture

Standard of Care CIPN management OTHER

Investigator directed standard of care management of CIPN

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Limitations and Caveats

Early termination due to low accrual leading to small number of subjects analyzed.

Results Point of Contact

• Title: Chair of Biostatistics Department
• Organization: Atrium Health Levine Cancer

james.symanowski@atriumhealth.org

9804422371

Study Officials

• Shamille Hariharan, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: September 15, 2021
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: January 27, 2025
• Results First Posted: January 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)