Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04770402

Enrollment

Registered

2021-02-25

Start date

2021-09-15

Completion date

2023-04-06

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Neuropathy, Multiple Myeloma

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.

Interventions

OTHERAcupuncture

12 acupuncture sessions over 10 weeks

OTHERStandard of Care CIPN management

Investigator directed standard of care management of CIPN

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy Who Received Acupuncture vs Standard of Care Management.	Approximately 10 weeks, from baseline measure to 10 week (+/- 1 week) measure.	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

Measure	Time frame	Description
Sleep Quality- FACT-GOG-NTX	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. The item is to rate the statement 'I am sleeping well.'
Constipation	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. The item is to rate the statement 'I have constipation.'
Dizziness	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. This item is to rate the statement 'I have dizziness'.
Dry Mouth	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. This item is to rate the statement 'I have dry mouth.'
General Health - CDC-HRQOL	approx. 10 weeks	General Health assessed through CDC-HRQOL Question 1 will be calculated for each subject as a 5- level ordinal variable from Poor to Excellent.
Specific Features of Chemotherapy-Induced Peripheral Neuropathy From FACT-GOG-NTX	10 weeks	Specific features of CIPN assessed through the subscale from FACT-GOG-NTX will be determined for each subject as a composite measure, which is calculated as the sum of the responses to the subscale questions. For subjects who complete all 12 subscale questions, the composite score will range from 0 to 48. Higher scores mean worse outcome
Nausea - FACT-GOG-NTX	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. The item is to rate the statement 'I have nausea.'
Sadness- FACT-GOG-NTX	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. The item is to rate the statement 'I feel sad'.
Nervousness- FACT-GOG-NTX	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. The item is to rate the statement 'I feel nervous.'
Lack of Energy- FACT-GOG-NTX	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. The item is to rate the statement 'I have a lack of energy.'
Pain- FACT-GOG-NTX	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. The item is to rate the statement 'I have pain.'

Other

Measure	Time frame	Description
Acupuncture Administration	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.
Acupuncture Expectancy	approx 10 weeks	The acupuncture expectancy score will be captured quantitatively for each subject as a composite score ranging from 4 to 20. Higher scores indicate higher expectancy of acupuncture.
Adverse Events of Special Interest	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, including bleeding, bruising, skin infection, edema, dry skin, urticaria, pruritus, rash, pain or flushing at the acupuncture site, or dizziness, syncope, fatigue, or hyperhidrosis.
Opioid Use	approx. 10 weeks	Opioid use will be calculated for each subject as a quantitative value assessed through Morphine Equivalent Daily Dose (MEDD).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Acupuncture Acupuncture: 12 acupuncture sessions over 10 weeks	8
Standard of Care Standard of Care CIPN management: Investigator directed standard of care management of CIPN	4
Total	12

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	2
Overall Study	Non-compliance	1	0
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Acupuncture	Total	Standard of Care
Age, Continuous	63.5 years	62.0 years	58.0 years
Baseline Chemotherapy-Induced Peripheral Neuropathy Score 4	0 Participants	2 Participants	2 Participants
Baseline Chemotherapy-Induced Peripheral Neuropathy Score 5	0 Participants	0 Participants	0 Participants
Baseline Chemotherapy-Induced Peripheral Neuropathy Score 6	4 Participants	4 Participants	0 Participants
Baseline Chemotherapy-Induced Peripheral Neuropathy Score 7	2 Participants	3 Participants	1 Participants
Baseline Chemotherapy-Induced Peripheral Neuropathy Score 8	2 Participants	2 Participants	0 Participants
Baseline Chemotherapy-Induced Peripheral Neuropathy Score 9	0 Participants	1 Participants	1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants	12 Participants	4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	4 Participants	6 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	4 Participants	6 Participants	2 Participants
Region of Enrollment United States	8 Participants	12 Participants	4 Participants
Sex: Female, Male Female	1 Participants	1 Participants	0 Participants
Sex: Female, Male Male	7 Participants	11 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 8	0 / 4
other Total, other adverse events	0 / 8	0 / 0
serious Total, serious adverse events	0 / 8	0 / 4

Outcome results

Primary

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.

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