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Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients

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ClinicalTrials.gov Identifier: NCT04770402
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Chasse Bailey Dorton, Atrium Health

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.

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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 : March 1, 2022
Estimated Study Completion Date : March 1, 2022


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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770402


Contacts
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Contact: Matthew Flores 980-442-7883 Matthew.Flores@atriumhealth.org

Locations
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United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Matthew Flores    980-442-7883    Matthew.Flores@atriumhealth.org   
Principal Investigator: Chasse Bailey-Dorton, MD         
Sponsors and Collaborators
Chasse Bailey Dorton
Investigators
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Principal Investigator: Chasse Bailey-Dorton, MD Atrium Health
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Responsible Party: Chasse Bailey Dorton, Chief, Section of Integrative Oncology, Atrium Health
ClinicalTrials.gov Identifier: NCT04770402    
Other Study ID Numbers: LCI-SUPP-MYE-ACUP-001
00049444 ( Other Identifier: Advarra IRB )
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chasse Bailey Dorton, Atrium Health:
Neuropathy
Multiple Myeloma
Additional relevant MeSH terms:
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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