Trial Outcomes & Findings for Acupuncture for Chemo-Induced Peripheral Neuropathy (NCT NCT00891618)
NCT ID: NCT00891618
Last Updated: 2016-10-31
Results Overview
Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Neurotoxicity Scale (FACT/GOG-Ntx) Version 4 used to assess efficacy of acupuncture for treatment-induced peripheral neuropathy among multiple myeloma and/or lymphoma patients. Severity of neuropathy measured by FACT-GOG-Ntx total score assessment where 11-item questionnaire 5 point rating scale (0="not at all" and 4=equals "very much"). FACT/GOG-Ntx Total Score ranges from 0 (best possible outcome) to 44 (worst possible outcome).
COMPLETED
PHASE2
27 participants
Baseline to Week 13. Assessments at baseline, once per week during the two treatment phases of the study, and one month (week 13) after the last acupuncture treatment.
2016-10-31
Participant Flow
Recruitment Period: April 30, 2009 to March 28, 2013. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.
Of the 27 participants registered, six participants were registered but excluded before treatment from the study.
Participant milestones
| Measure |
Acupuncture
Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Acupuncture
Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Acupuncture for Chemo-Induced Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Acupuncture
n=21 Participants
Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 13. Assessments at baseline, once per week during the two treatment phases of the study, and one month (week 13) after the last acupuncture treatment.Population: Participants were excluded from primary outcome if did not complete follow up assessments.
Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Neurotoxicity Scale (FACT/GOG-Ntx) Version 4 used to assess efficacy of acupuncture for treatment-induced peripheral neuropathy among multiple myeloma and/or lymphoma patients. Severity of neuropathy measured by FACT-GOG-Ntx total score assessment where 11-item questionnaire 5 point rating scale (0="not at all" and 4=equals "very much"). FACT/GOG-Ntx Total Score ranges from 0 (best possible outcome) to 44 (worst possible outcome).
Outcome measures
| Measure |
Acupuncture
n=19 Participants
Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
|
|---|---|
|
Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)
Baseline (n=19)
|
20.8 units on a scale
Standard Deviation 9.6
|
|
Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)
Week 4 (n=18)
|
16.7 units on a scale
Standard Deviation 9.4
|
|
Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)
Week 9 (n=15)
|
9.9 units on a scale
Standard Deviation 5.6
|
|
Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)
Week 13 (n=15)
|
13.2 units on a scale
Standard Deviation 8.5
|
Adverse Events
Acupuncture
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Wang, MD / Professor, Lymphoma/Myeloma
University of Texas MD Anderson Cancer
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place