Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients

• ClinicalTrials.gov Identifier: NCT04770402
• Recruitment Status: Recruiting
• First Posted: February 25, 2021
• Last Update Posted: May 8, 2023
• Sponsor: Wake Forest University Health Sciences
• Collaborator: Atrium Health Levine Cancer Institute
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chemotherapy-induced Peripheral Neuropathy	Other: Acupuncture; Other: Standard of Care CIPN management	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Acupuncture for Chemo-Induced Peripheral Neuropathy (CIPN) in Multiple Myeloma (MM) Patients- A Randomized Controlled Trial
• Actual Study Start Date: September 15, 2021
• Estimated Primary Completion Date: December 1, 2023
• Estimated Study Completion Date: December 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Acupuncture	Other: Acupuncture; 12 acupuncture sessions over 10 weeks
Active Comparator: Standard of Care	Other: Standard of Care CIPN management; Investigator directed standard of care management of CIPN

Outcome Measures

Primary Outcome Measures :

1. Evaluate the change of neuropathy in actively treated multiple myeloma subjects diagnosed with CIPN who received acupuncture vs standard of care management. [ Time Frame: approx. 10 weeks ]
   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 :

1. Assess Specific features of CIPN - Nausea [ Time Frame: 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
2. Assess Specific features of CIPN - Sadness [ Time Frame: 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.
3. Assess Specific features of CIPN - Nervousness [ Time Frame: 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.
4. Assess Specific features of CIPN - Sleep quality [ Time Frame: 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.
5. Assess Specific features of CIPN - Lack of energy [ Time Frame: 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.
6. Assess Specific features of CIPN - Pain [ Time Frame: 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.
7. Assess Specific features of CIPN - Constipation [ Time Frame: 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.
8. Assess Specific features of CIPN - Dizziness [ Time Frame: 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.
9. Assess Specific features of CIPN - Dry Mouth [ Time Frame: 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.
10. Assess Quality of Life [ Time Frame: approx. 10 weeks ]
    Quality of life will be determined quantitatively using CDC HRQoL-4 questionnaire indicating number of days QOL has been impacted.

Other Outcome Measures:

1. Assess Adverse Events of Special Interest [ Time Frame: approx. 10 weeks ]
   Adverse Events of Special Interest (AESI) will be determined for each subject as binary variables indicating whether or not they experienced a protocol defined AESI.
2. Assess Opioid Use [ Time Frame: approx. 10 weeks ]
   Opioid use will be calculated for each subject as a quantitative value assessed through Morphine Equivalent Daily Dose (MEDD).
3. Assess Concomitant medication use [ Time Frame: approx. 10 weeks ]
   Concomitant medication use will be determined for each subject assessed through medication name and dose.
4. Assess Bortezomib dose modification [ Time Frame: approx. 10 weeks ]
   The frequency of bortezomib dose modification (delays and reductions) will be determined for each subject as a count variable.
5. Assess Bortezomib administration [ Time Frame: approx. 10 weeks ]
   Bortezomib administration will be assessed for each subject in terms of total number of cycles given and cumulative dose from Randomization
6. Evaluate dose response based on Acupuncture administration [ Time Frame: approx. 10 weeks ]
   Acupuncture administration will be defined for each subject on the acupuncture arm as the number of attended acupuncture sessions from 0 to 12.
7. Evaluate the effect of Acupuncture expectancy [ Time Frame: approx. 10 weeks ]
   The acupuncture expectancy score will be captured quantitatively for each subject as a composite score ranging from 4 to 20.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Jake Waldman; 980-442-7826; Jake.Waldman@atriumhealth.org

Locations

United States, North Carolina

Levine Cancer Institute; Recruiting

Charlotte, North Carolina, United States, 28204

Contact: Jake Waldman 980-442-7826 Jake.Waldman@atriumhealth.org

Principal Investigator: Shamille Hariharan, MD

Sponsors and Collaborators

Wake Forest University Health Sciences

Atrium Health Levine Cancer Institute

Investigators

• Principal Investigator: Shamille Hariharan, MD; Wake Forest University Health Sciences

More Information

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT04770402
• Other Study ID Numbers: IRB00081364; 00049444 ( Other Identifier: Advarra IRB ); LCI-SUPP-MYE-ACUP-001 ( Other Identifier: Atrium Health )
• First Posted: February 25, 2021
• Last Update Posted: May 8, 2023
• Last Verified: May 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:

Neuropathy; Multiple Myeloma

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Peripheral Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases