Trial Outcomes & Findings for Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women (NCT NCT04067544)
NCT ID: NCT04067544
Last Updated: 2025-04-06
Results Overview
We calculated the mean number of participants who enrolled per month while the study was open to accrual.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
7 Months
Results posted on
2025-04-06
Participant Flow
Participant milestones
| Measure |
Acupuncture Treatment
All participants receive 10 acupuncture treatments over the course of 8 weeks.
Acupuncture: The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
Participants in the study will undergo study interview and functional magnetic resonance imaging (fMRI) at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.
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|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Acupuncture Treatment
All participants receive 10 acupuncture treatments over the course of 8 weeks.
Acupuncture: The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
Participants in the study will undergo study interview and functional magnetic resonance imaging (fMRI) at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.
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|---|---|
|
Overall Study
Unforeseen recruitment issues due to Coronavirus Disease (COVID)-19 pandemic
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1
|
Baseline Characteristics
Only participants who completed all questionnaires were evaluable for the questionnaire-related outcome (i.e. Outcome 6), so this baseline measure also only reports questionnaires completed by participants who were evaluated for that outcome.
Baseline characteristics by cohort
| Measure |
Acupuncture Treatment
n=3 Participants
All participants receive 10 acupuncture treatments over the course of 8 weeks.
Acupuncture: The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
Participants in the study will undergo study interview and fMRI at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Female
|
3 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
|
Participant reported symptoms at baseline
|
74.13 score on a scale
STANDARD_DEVIATION 15.468 • n=2 Participants • Only participants who completed all questionnaires were evaluable for the questionnaire-related outcome (i.e. Outcome 6), so this baseline measure also only reports questionnaires completed by participants who were evaluated for that outcome.
|
PRIMARY outcome
Timeframe: 7 MonthsWe calculated the mean number of participants who enrolled per month while the study was open to accrual.
Outcome measures
| Measure |
Acupuncture Treatment
n=3 Participants
All participants receive 10 acupuncture treatments over the course of 8 weeks.
Acupuncture: The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
Participants in the study will undergo study interview and fMRI at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.
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|---|---|
|
Mean Monthly Enrollment
|
0.429 participants per month
Standard Deviation 0.787
|
PRIMARY outcome
Timeframe: 7 MonthsParticipant retention was defined as the number of participants who attended at least 8 out of 10 AT sessions and completed both fMRI scans
Outcome measures
| Measure |
Acupuncture Treatment
n=3 Participants
All participants receive 10 acupuncture treatments over the course of 8 weeks.
Acupuncture: The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
Participants in the study will undergo study interview and fMRI at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.
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|---|---|
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Number of Participants Compliant With Treatment
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2 Participants
|
PRIMARY outcome
Timeframe: 7 MonthsA serious adverse event is any undesirable experience associated with the participation in this study in a participant that results in death, life-threatening conditions, hospitalization, disability or permanent damage or birth defect.
Outcome measures
| Measure |
Acupuncture Treatment
n=3 Participants
All participants receive 10 acupuncture treatments over the course of 8 weeks.
Acupuncture: The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
Participants in the study will undergo study interview and fMRI at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.
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|---|---|
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Number of Participants Who Experience Serious Adverse Events Related to AT Sessions
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0 Participants
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PRIMARY outcome
Timeframe: 7 MonthsParticipants who completed all questionnaires, which were administered at baseline and at 3 months post-treatment.
Outcome measures
| Measure |
Acupuncture Treatment
n=3 Participants
All participants receive 10 acupuncture treatments over the course of 8 weeks.
Acupuncture: The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
Participants in the study will undergo study interview and fMRI at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.
|
|---|---|
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Number of Participants Who Completed Questionnaires
|
2 Participants
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SECONDARY outcome
Timeframe: 9 weeksConnectivity changes were evaluated using resting-state fMRI at baseline and post-treatment. Independent component analysis was used to identify networks, and statistical thresholds were applied to define significant changes. Z-scores represent standard deviations from the mean of a normative reference population, with positive values indicating increased connectivity and negative values indicating decreased connectivity.
Outcome measures
| Measure |
Acupuncture Treatment
n=2 Participants
All participants receive 10 acupuncture treatments over the course of 8 weeks.
Acupuncture: The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
Participants in the study will undergo study interview and fMRI at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.
|
|---|---|
|
Change in Functional Connectivity of Central Pain Networks on fMRI (Z-scores)
|
3.32 Z-Score
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: 22 weeksPopulation: Only 2 participants completed all 3 questionnaires so only these scores were used.
Quality of Life Questionnaire (QLQ) - Chemotherapy Induced Peripheral Neuropathy (CIPN) 20 (QLQ-CIPN-20) questionnaire is administered to participants at baseline (BL) and at 3 months post-treatment (approximately 22 weeks total between time points). Mean difference between BL and 3 Month Questionnaire scores will be calculated. Only participants who have completed all questionnaires will be evaluated. The 20-item questionnaire is scored using a four-point Likert-type scale ranging from 1 (not at all) to 4 (very much), and evaluates sensory (9 items), motor (8 items), and autonomic (3 items for men, 2 items for women) symptom subscales. Items from each subscale are summed, then linearly converted to a 0-100 scale. The three subscale scores are averaged to obtain a total score, with the final score range being 0-100. For raw and scaled scores, higher scores indicate more symptoms of peripheral neuropathy.
Outcome measures
| Measure |
Acupuncture Treatment
n=2 Participants
All participants receive 10 acupuncture treatments over the course of 8 weeks.
Acupuncture: The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
Participants in the study will undergo study interview and fMRI at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.
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|---|---|
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Change in Participant-reported Symptoms From Before AT to After Study Completion
|
-25.17 change in score on a scale
Standard Deviation 5.156
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 22 weeksPopulation: Only two participants completed questionnaires at 3 months post treatment
Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy 20 (QLQ-CIPN-20) questionnaire is administered to participants at baseline (BL) and at 3 months post-treatment (approximately 22 weeks total between time points). This outcome reports mean participant scores at 3 months post treatment. Only participants who have completed all questionnaires will be evaluated. The 20-item questionnaire is scored using a four-point Likert-type scale ranging from 1 (not at all) to 4 (very much), and evaluates sensory (9 items), motor (8 items), and autonomic (3 items for men, 2 items for women) symptom subscales. Items from each subscale are summed, then linearly converted to a 0-100 scale. The three subscale scores are averaged to obtain a total score, with the final score range being 0-100. For raw and scaled scores, higher scores indicate more symptoms of peripheral neuropathy.
Outcome measures
| Measure |
Acupuncture Treatment
n=2 Participants
All participants receive 10 acupuncture treatments over the course of 8 weeks.
Acupuncture: The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
Participants in the study will undergo study interview and fMRI at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.
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|---|---|
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Participant Reported Symptoms 3 Months Post Treatment
|
48.96 score on a scale
Standard Deviation 20.624
|
Adverse Events
Acupuncture Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acupuncture Treatment
n=3 participants at risk
All participants receive 10 acupuncture treatments over the course of 8 weeks.
Acupuncture: The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
Participants in the study will undergo study interview and fMRI at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion.
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|---|---|
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General disorders
localized edema
|
33.3%
1/3 • Number of events 1 • From start of acupuncture treatment (AT) to 12 weeks following discontinuation of AT (approximately 22 weeks per patient)
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • From start of acupuncture treatment (AT) to 12 weeks following discontinuation of AT (approximately 22 weeks per patient)
|
Additional Information
Lisa Taylor-Swanson
University of Utah College of Nursing
Phone: 801.585.5486
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place