NCT04770402 · REGISTRY CONDITION SEARCH

Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: TERMINATED
Registry last update: 2025-01-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy Who Received Acupuncture vs Standard of Care Management.

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outcome · POSTED

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

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outcome · POSTED

Nausea - FACT-GOG-NTX

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outcome · POSTED

Sadness- FACT-GOG-NTX

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outcome · POSTED

Nervousness- FACT-GOG-NTX

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outcome · POSTED

Sleep Quality- FACT-GOG-NTX

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outcome · POSTED

Lack of Energy- FACT-GOG-NTX

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outcome · POSTED

Pain- FACT-GOG-NTX

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outcome · POSTED

Constipation

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outcome · POSTED

Dizziness

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outcome · POSTED

Dry Mouth

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outcome · POSTED

General Health - CDC-HRQOL

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outcome · POSTED

Adverse Events of Special Interest

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outcome · POSTED

Opioid Use

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outcome · POSTED

Acupuncture Administration

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outcome · POSTED

Acupuncture Expectancy

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Subjects on this arm will receive 12 sessions of acupuncture over approximately 10 weeks, along with continued standard treatment by their physician.
intervention Names
Other: Acupuncture
label
Acupuncture
type
EXPERIMENTAL
description
Subjects on this arm will not receive acupuncture, but will continue to be followed by their physician with standard treatment for their neuropathy.
intervention Names
Other: Standard of Care CIPN management
label
Standard of Care
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Acupuncture
description
12 acupuncture sessions over 10 weeks
name
Acupuncture
type
OTHER
arm Group Labels
Standard of Care
description
Investigator directed standard of care management of CIPN
name
Standard of Care CIPN management
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 12
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
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.
measure
Adverse Events of Special Interest
time Frame
approx. 10 weeks
description
Opioid use will be calculated for each subject as a quantitative value assessed through Morphine Equivalent Daily Dose (MEDD).
measure
Opioid Use
time Frame
approx. 10 weeks
description
Acupuncture administration will be defined for each subject on the acupuncture arm as the number of attended acupuncture sessions from 0 to 12.
measure
Acupuncture Administration
time Frame
approx. 10 weeks
description
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.
measure
Acupuncture Expectancy
time Frame
approx 10 weeks

primary Outcomes

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

secondary Outcomes

description
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
measure
Specific Features of Chemotherapy-Induced Peripheral Neuropathy From FACT-GOG-NTX
time Frame
10 weeks
description
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.'
measure
Nausea - FACT-GOG-NTX
time Frame
approx. 10 weeks
description
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'.
measure
Sadness- FACT-GOG-NTX
time Frame
approx. 10 weeks
description
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.'
measure
Nervousness- FACT-GOG-NTX
time Frame
approx. 10 weeks
description
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.'
measure
Sleep Quality- FACT-GOG-NTX
time Frame
approx. 10 weeks
description
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.'
measure
Lack of Energy- FACT-GOG-NTX
time Frame
approx. 10 weeks
description
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.'
measure
Pain- FACT-GOG-NTX
time Frame
approx. 10 weeks
description
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.'
measure
Constipation
time Frame
approx. 10 weeks
description
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'.
measure
Dizziness
time Frame
approx. 10 weeks
description
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.'
measure
Dry Mouth
time Frame
approx. 10 weeks
description
General Health assessed through CDC-HRQOL Question 1 will be calculated for each subject as a 5- level ordinal variable from Poor to Excellent.
measure
General Health - CDC-HRQOL
time Frame
approx. 10 weeks

Full 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.
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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice