NCT04770402

Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients

Terminated NA Results posted Last updated 27 January 2025

What this trial tests

NA trial testing Acupuncture in Chemotherapy-induced Peripheral Neuropathy in 12 participants. Terminated before completion.

Timeline

15 September 2021

Primary endpoint
6 April 2023

6 April 2023

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	12
Start date	15 September 2021
Primary completion	6 April 2023
Estimated completion	6 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Acupuncture — full drug profile →
• Standard of Care CIPN management

Conditions studied

• Chemotherapy-induced Peripheral Neuropathy — all drugs for Chemotherapy-induced Peripheral Neuropathy →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Chemotherapy-induced Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Acupuncture	6
Standard of Care	0
Acupuncture	1
Standard of Care	1

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

Group	Value	95% CI
Acupuncture	14.0	5.0 – 27.0
Standard of Care	23.0	23.0 – 23.0

Nausea - FACT-GOG-NTX Secondary · 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.'

Group	Value	95% CI
Acupuncture	7
Standard of Care	1
Acupuncture	0
Standard of Care	0
Acupuncture	0
Standard of Care	0
Acupuncture	0
Standard of Care	0

Sadness- FACT-GOG-NTX Secondary · 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'.

Group	Value	95% CI
Acupuncture	4
Standard of Care	1
Acupuncture	2
Standard of Care	0
Acupuncture	1
Standard of Care	0
Acupuncture	0
Standard of Care	0

Nervousness- FACT-GOG-NTX Secondary · 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.'

Group	Value	95% CI
Acupuncture	4
Standard of Care	1
Acupuncture	3
Standard of Care	0
Acupuncture	0
Standard of Care	0
Acupuncture	0
Standard of Care	0

Sleep Quality- FACT-GOG-NTX Secondary · 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.'

Group	Value	95% CI
Acupuncture	0
Standard of Care	0
Acupuncture	0
Standard of Care	0
Acupuncture	4
Standard of Care	0
Acupuncture	2
Standard of Care	0

Lack of Energy- FACT-GOG-NTX Secondary · 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.'

Group	Value	95% CI
Acupuncture	2
Standard of Care	0
Acupuncture	3
Standard of Care	0
Acupuncture	2
Standard of Care	1
Acupuncture	0
Standard of Care	0

Pain- FACT-GOG-NTX Secondary · 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.'

Group	Value	95% CI
Acupuncture	1
Standard of Care	0
Acupuncture	3
Standard of Care	0
Acupuncture	2
Standard of Care	0
Acupuncture	1
Standard of Care	1

Constipation Secondary · 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.'

Group	Value	95% CI
Acupuncture	0
Standard of Care	0
Acupuncture	5
Standard of Care	0
Acupuncture	1
Standard of Care	1
Acupuncture	1
Standard of Care	0

Dizziness Secondary · 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'.

Group	Value	95% CI
Acupuncture	1
Standard of Care	0
Acupuncture	3
Standard of Care	1
Acupuncture	2
Standard of Care	0
Acupuncture	1
Standard of Care	0

Dry Mouth Secondary · 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.'

Group	Value	95% CI
Acupuncture	1
Standard of Care	0
Acupuncture	5
Standard of Care	0
Acupuncture	0
Standard of Care	1
Acupuncture	1
Standard of Care	0

General Health - CDC-HRQOL Secondary · 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.

Group	Value	95% CI
Acupuncture	0
Standard of Care	0
Acupuncture	1
Standard of Care	0
Acupuncture	4
Standard of Care	1
Acupuncture	2
Standard of Care	0

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging Approaches for the Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN): Therapeutic Potential of the C5a/C5aR Axis.
   Spera MC, Cesta MC, Zippoli M, Varrassi G, et al · · 2022 · cited 10× · PMID 36098939 · DOI 10.1007/s40122-022-00431-8
2. News from the Field
   · 2021