Trial Outcomes & Findings for Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients (NCT NCT04770402)

NCT ID: NCT04770402

Last Updated: 2025-01-27

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Approximately 10 weeks, from baseline measure to 10 week (+/- 1 week) measure.
• Results posted on: 2025-01-27

Participant Flow

Participant milestones

Measure	Acupuncture Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Overall Study STARTED	8	4
Overall Study COMPLETED	6	1
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Acupuncture Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Overall Study Lost to Follow-up	1	2
Overall Study Non-compliance	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients

Baseline characteristics by cohort

Measure	Acupuncture n=8 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=4 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN	Total n=12 Participants Total of all reporting groups
Age, Continuous	63.5 years n=5 Participants	58.0 years n=7 Participants	62.0 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Baseline Chemotherapy-Induced Peripheral Neuropathy Score 4	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Baseline Chemotherapy-Induced Peripheral Neuropathy Score 5	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Chemotherapy-Induced Peripheral Neuropathy Score 6	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Baseline Chemotherapy-Induced Peripheral Neuropathy Score 7	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Baseline Chemotherapy-Induced Peripheral Neuropathy Score 8	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Baseline Chemotherapy-Induced Peripheral Neuropathy Score 9	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

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

Population: The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.

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.

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=1 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy Who Received Acupuncture vs Standard of Care Management. Experienced at least a 2 point improvement in neuropathy between baseline and Week 10	6 Participants	0 Participants
Change of Neuropathy in Actively Treated Multiple Myeloma Subjects Diagnosed With Chemotherapy-induced Peripheral Neuropathy Who Received Acupuncture vs Standard of Care Management. Did not experience at least a 2 point improvement in neuropathy between baseline and Week 10	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 10 weeks

Population: The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.

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

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=1 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Specific Features of Chemotherapy-Induced Peripheral Neuropathy From FACT-GOG-NTX	14.0 Score on a scale Interval 5.0 to 27.0	23.0 Score on a scale Interval 23.0 to 23.0

SECONDARY outcome

Timeframe: approx. 10 weeks

Population: The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.

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.'

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=1 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Nausea - FACT-GOG-NTX Not at all	7 Participants	1 Participants
Nausea - FACT-GOG-NTX A little bit	0 Participants	0 Participants
Nausea - FACT-GOG-NTX Somewhat	0 Participants	0 Participants
Nausea - FACT-GOG-NTX Quite a bit	0 Participants	0 Participants
Nausea - FACT-GOG-NTX Very much	0 Participants	0 Participants

SECONDARY outcome

Timeframe: approx. 10 weeks

Population: The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.

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'.

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=1 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Sadness- FACT-GOG-NTX Not at all	4 Participants	1 Participants
Sadness- FACT-GOG-NTX A little bit	2 Participants	0 Participants
Sadness- FACT-GOG-NTX Somewhat	1 Participants	0 Participants
Sadness- FACT-GOG-NTX Quite a bit	0 Participants	0 Participants
Sadness- FACT-GOG-NTX Very much	0 Participants	0 Participants

SECONDARY outcome

Timeframe: approx. 10 weeks

Population: The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.

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.'

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=1 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Nervousness- FACT-GOG-NTX Not at all	4 Participants	1 Participants
Nervousness- FACT-GOG-NTX A little bit	3 Participants	0 Participants
Nervousness- FACT-GOG-NTX Somewhat	0 Participants	0 Participants
Nervousness- FACT-GOG-NTX Quite a bit	0 Participants	0 Participants
Nervousness- FACT-GOG-NTX Very much	0 Participants	0 Participants

SECONDARY outcome

Timeframe: approx. 10 weeks

Population: The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.

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.'

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=1 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Sleep Quality- FACT-GOG-NTX Not at all	0 Participants	0 Participants
Sleep Quality- FACT-GOG-NTX A little bit	0 Participants	0 Participants
Sleep Quality- FACT-GOG-NTX Somewhat	4 Participants	0 Participants
Sleep Quality- FACT-GOG-NTX Quite a bit	2 Participants	0 Participants
Sleep Quality- FACT-GOG-NTX Very much	1 Participants	1 Participants

SECONDARY outcome

Timeframe: approx. 10 weeks

Population: The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.

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.'

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=1 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Lack of Energy- FACT-GOG-NTX Not at all	2 Participants	0 Participants
Lack of Energy- FACT-GOG-NTX A little bit	3 Participants	0 Participants
Lack of Energy- FACT-GOG-NTX Somewhat	2 Participants	1 Participants
Lack of Energy- FACT-GOG-NTX Quite a bit	0 Participants	0 Participants
Lack of Energy- FACT-GOG-NTX Very much	0 Participants	0 Participants

SECONDARY outcome

Timeframe: approx. 10 weeks

Population: The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.

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.'

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=1 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Pain- FACT-GOG-NTX Not at all	1 Participants	0 Participants
Pain- FACT-GOG-NTX Very little	3 Participants	0 Participants
Pain- FACT-GOG-NTX Somewhat	2 Participants	0 Participants
Pain- FACT-GOG-NTX Quite a bit	1 Participants	1 Participants
Pain- FACT-GOG-NTX Very much	0 Participants	0 Participants

SECONDARY outcome

Timeframe: approx. 10 weeks

Population: The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.

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.'

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=1 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Constipation Not at all	0 Participants	0 Participants
Constipation A little bit	5 Participants	0 Participants
Constipation Somewhat	1 Participants	1 Participants
Constipation Quite a bit	1 Participants	0 Participants
Constipation Very much	0 Participants	0 Participants

SECONDARY outcome

Timeframe: approx. 10 weeks

Population: The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.

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'.

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=1 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Dizziness Not at all	1 Participants	0 Participants
Dizziness A little bit	3 Participants	1 Participants
Dizziness Somewhat	2 Participants	0 Participants
Dizziness Quite a bit	1 Participants	0 Participants
Dizziness Very much	0 Participants	0 Participants

SECONDARY outcome

Timeframe: approx. 10 weeks

Population: The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.

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.'

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=1 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Dry Mouth Not at all	1 Participants	0 Participants
Dry Mouth A little bit	5 Participants	0 Participants
Dry Mouth Somewhat	0 Participants	1 Participants
Dry Mouth Quite a bit	1 Participants	0 Participants
Dry Mouth Very much	0 Participants	0 Participants

SECONDARY outcome

Timeframe: approx. 10 weeks

Population: The analysis population are those that met the evaluable population criteria, which was enrolled subjects who have complete baseline and Week 10 neuropathy scores.

General Health assessed through CDC-HRQOL Question 1 will be calculated for each subject as a 5- level ordinal variable from Poor to Excellent.

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=1 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
General Health - CDC-HRQOL Excellent	0 Participants	0 Participants
General Health - CDC-HRQOL Very good	1 Participants	0 Participants
General Health - CDC-HRQOL Good	4 Participants	1 Participants
General Health - CDC-HRQOL Fair	2 Participants	0 Participants
General Health - CDC-HRQOL Poor	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: approx. 10 weeks

Population: Enrolled participants on the acupuncture arm

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.

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Adverse Events of Special Interest	0 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: approx. 10 weeks

Population: All participants receiving acupuncture or standard of care

Opioid use will be calculated for each subject as a quantitative value assessed through Morphine Equivalent Daily Dose (MEDD).

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care n=4 Participants Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Opioid Use	0.0 morphine milligram equivalents per day Interval 0.0 to 0.0	82.5 morphine milligram equivalents per day Interval 15.0 to 150.0

OTHER_PRE_SPECIFIED outcome

Timeframe: approx. 10 weeks

Population: Enrolled participants randomized to the acupuncture arm

Acupuncture administration will be defined for each subject on the acupuncture arm as the number of attended acupuncture sessions from 0 to 12.

Outcome measures

Measure	Acupuncture n=7 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Acupuncture Administration	11 number of acupuncture sessions Interval 9.0 to 12.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: approx 10 weeks

Population: Participants randomized to the acupuncture arm

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.

Outcome measures

Measure	Acupuncture n=8 Participants Acupuncture: 12 acupuncture sessions over 10 weeks	Standard of Care Standard of Care CIPN management: Investigator directed standard of care management of CIPN
Acupuncture Expectancy	13 Score on a scale Interval 7.0 to 20.0	—

Adverse Events

Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chair of Biostatistics Department

Atrium Health Levine Cancer

Phone: 9804422371

Email: james.symanowski@atriumhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place