Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

Acupuncture for Chemo-Induced Peripheral Neuropathy (CIPN) in Multiple Myeloma (MM) Patients- A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04770402
• Other study ID #: IRB00081364
• Secondary ID: 00049444LCI-SUPP
• Status: Terminated
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: April 6, 2023

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 6, 2023
• Est. primary completion date: April 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Peripheral Nervous System Diseases

Intervention

Other:
• Acupuncture
12 acupuncture sessions over 10 weeks
• Standard of Care CIPN management
Investigator directed standard of care management of CIPN

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Atrium Health Levine Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess Adverse Events of Special Interest	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.	approx. 10 weeks
Other	Assess Opioid Use	Opioid use will be calculated for each subject as a quantitative value assessed through Morphine Equivalent Daily Dose (MEDD).	approx. 10 weeks
Other	Assess Concomitant medication use	Concomitant medication use will be determined for each subject assessed through medication name and dose.	approx. 10 weeks
Other	Assess Bortezomib dose modification	The frequency of bortezomib dose modification (delays and reductions) will be determined for each subject as a count variable.	approx. 10 weeks
Other	Assess Bortezomib administration	Bortezomib administration will be assessed for each subject in terms of total number of cycles given and cumulative dose from Randomization	approx. 10 weeks
Other	Evaluate dose response based on Acupuncture administration	Acupuncture administration will be defined for each subject on the acupuncture arm as the number of attended acupuncture sessions from 0 to 12.	approx. 10 weeks
Other	Evaluate the effect of Acupuncture expectancy	The acupuncture expectancy score will be captured quantitatively for each subject as a composite score ranging from 4 to 20.	approx. 10 weeks
Primary	Evaluate the change of neuropathy in actively treated multiple myeloma subjects diagnosed with CIPN 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.	approx. 10 weeks
Secondary	Assess Specific features of CIPN - Nausea	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	approx. 10 weeks
Secondary	Assess Specific features of CIPN - Sadness	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.	approx. 10 weeks
Secondary	Assess Specific features of CIPN - Nervousness	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.	approx. 10 weeks
Secondary	Assess Specific features of CIPN - Sleep quality	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.	approx. 10 weeks
Secondary	Assess Specific features of CIPN - Lack of energy	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.	approx. 10 weeks
Secondary	Assess Specific features of CIPN - Pain	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.	approx. 10 weeks
Secondary	Assess Specific features of CIPN - Constipation	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.	approx. 10 weeks
Secondary	Assess Specific features of CIPN - Dizziness	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.	approx. 10 weeks
Secondary	Assess Specific features of CIPN - Dry Mouth	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.	approx. 10 weeks
Secondary	Assess Quality of Life	Quality of life will be determined quantitatively using CDC HRQoL-4 questionnaire indicating number of days QOL has been impacted.	approx. 10 weeks