Trial Outcomes & Findings for Acupressure for Fatigue in Ovarian Cancer Survivors (NCT NCT03763838)
NCT ID: NCT03763838
Last Updated: 2026-02-05
Results Overview
Self-reported on the Brief Fatigue Inventory (BFI). The Brief Fatigue Inventory (BFI) uses a scale of 0 to 10 for each item, with 0 representing "no fatigue" and 10 representing "fatigue as bad as you can imagine". Scores are then categorized as mild (1-3), moderate (4-6), and severe (7-10). The global BFI score is calculated as the average of all items, and a score of 7 or greater is considered clinically significant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
171 participants
Primary outcome timeframe
Baseline to week 6
Results posted on
2026-02-05
Participant Flow
Acupressure plus standard of care- 58 participants allocated, 5 participants did not start treatment. Sham plus standard of care- 58 participants allocated, 2 participants did not start treatment. Standard of care- 55 participants allocated, 4 participants did not start treatment.
Participant milestones
| Measure |
Acupressure Plus Standard of Care
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Acupressure: Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
Standard of Care: Fatigue management provided by participants' health care providers.
|
Sham Acupressure Plus Standard of Care
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Sham acupressure: Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
Standard of Care: Fatigue management provided by participants' health care providers.
|
Standard of Care
Participants will receive standard of care only.
Standard of Care: Fatigue management provided by participants' health care providers.
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
55
|
|
Overall Study
COMPLETED
|
37
|
40
|
46
|
|
Overall Study
NOT COMPLETED
|
21
|
18
|
9
|
Reasons for withdrawal
| Measure |
Acupressure Plus Standard of Care
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Acupressure: Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
Standard of Care: Fatigue management provided by participants' health care providers.
|
Sham Acupressure Plus Standard of Care
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Sham acupressure: Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
Standard of Care: Fatigue management provided by participants' health care providers.
|
Standard of Care
Participants will receive standard of care only.
Standard of Care: Fatigue management provided by participants' health care providers.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
9
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
|
Overall Study
Disease Reoccurrence
|
0
|
2
|
0
|
|
Overall Study
participants did not start treatment.
|
5
|
2
|
4
|
Baseline Characteristics
Acupressure for Fatigue in Ovarian Cancer Survivors
Baseline characteristics by cohort
| Measure |
Acupressure Plus Standard of Care
n=58 Participants
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Acupressure: Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
Standard of Care: Fatigue management provided by participants' health care providers.
|
Sham Acupressure Plus Standard of Care
n=58 Participants
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Sham acupressure: Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
Standard of Care: Fatigue management provided by participants' health care providers.
|
Standard of Care
n=55 Participants
Participants will receive standard of care only.
Standard of Care: Fatigue management provided by participants' health care providers.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
57 years
STANDARD_DEVIATION 10 • n=41 Participants
|
55 years
STANDARD_DEVIATION 12 • n=1581 Participants
|
57 years
STANDARD_DEVIATION 12 • n=4626 Participants
|
57 years
STANDARD_DEVIATION 13 • n=72 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=41 Participants
|
58 Participants
n=1581 Participants
|
55 Participants
n=4626 Participants
|
171 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
4 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
2 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
4 Participants
n=72 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=41 Participants
|
51 Participants
n=1581 Participants
|
45 Participants
n=4626 Participants
|
147 Participants
n=72 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
13 Participants
n=72 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=41 Participants
|
58 participants
n=1581 Participants
|
55 participants
n=4626 Participants
|
171 participants
n=72 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 6Population: evaluable patients at week 6
Self-reported on the Brief Fatigue Inventory (BFI). The Brief Fatigue Inventory (BFI) uses a scale of 0 to 10 for each item, with 0 representing "no fatigue" and 10 representing "fatigue as bad as you can imagine". Scores are then categorized as mild (1-3), moderate (4-6), and severe (7-10). The global BFI score is calculated as the average of all items, and a score of 7 or greater is considered clinically significant.
Outcome measures
| Measure |
Acupressure Plus Standard of Care
n=41 Participants
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Acupressure: Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
Standard of Care: Fatigue management provided by participants' health care providers.
|
Sham Acupressure Plus Standard of Care
n=45 Participants
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Sham acupressure: Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
Standard of Care: Fatigue management provided by participants' health care providers.
|
Standard of Care
n=51 Participants
Participants will receive standard of care only.
Standard of Care: Fatigue management provided by participants' health care providers.
|
|---|---|---|---|
|
Change in Level of Fatigue at Week 6
Baseline
|
5.57 mean score
Interval 5.09 to 6.06
|
5.30 mean score
Interval 4.81 to 5.79
|
5.38 mean score
Interval 4.91 to 5.85
|
|
Change in Level of Fatigue at Week 6
Week 6
|
3.52 mean score
Interval 3.02 to 4.01
|
4.06 mean score
Interval 3.6 to 4.53
|
4.96 mean score
Interval 4.52 to 5.4
|
PRIMARY outcome
Timeframe: Baseline up to week 24Population: evaluable patients at 24 weeks
Self-reported on the Brief Fatigue Inventory (BFI). The Brief Fatigue Inventory (BFI) uses a scale of 0 to 10 for each item, with 0 representing "no fatigue" and 10 representing "fatigue as bad as you can imagine". Scores are then categorized as mild (1-3), moderate (4-6), and severe (7-10). The global BFI score is calculated as the average of all items, and a score of 7 or greater is considered clinically significant.
Outcome measures
| Measure |
Acupressure Plus Standard of Care
n=37 Participants
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Acupressure: Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
Standard of Care: Fatigue management provided by participants' health care providers.
|
Sham Acupressure Plus Standard of Care
n=40 Participants
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Sham acupressure: Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
Standard of Care: Fatigue management provided by participants' health care providers.
|
Standard of Care
n=46 Participants
Participants will receive standard of care only.
Standard of Care: Fatigue management provided by participants' health care providers.
|
|---|---|---|---|
|
Change in Level of Fatigue up to Week 24
Baseline
|
5.57 mean score
Interval 5.09 to 6.06
|
5.30 mean score
Interval 4.81 to 5.79
|
5.38 mean score
Interval 4.91 to 5.85
|
|
Change in Level of Fatigue up to Week 24
Week 24
|
3.55 mean score
Interval 2.81 to 4.29
|
4.09 mean score
Interval 3.36 to 4.82
|
5.15 mean score
Interval 4.63 to 5.68
|
SECONDARY outcome
Timeframe: Baseline to week 6Population: number of patients evaluable at 6 weeks
Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O). The FACT-O is a questionnaire used to assess the quality of life in women with ovarian cancer. It includes 7 items, each scored from 0 to 4, with higher scores representing a more positive quality of life. Mean scores are reported by arm and timepoint. score range of 0-28.
Outcome measures
| Measure |
Acupressure Plus Standard of Care
n=53 Participants
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Acupressure: Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
Standard of Care: Fatigue management provided by participants' health care providers.
|
Sham Acupressure Plus Standard of Care
n=56 Participants
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Sham acupressure: Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
Standard of Care: Fatigue management provided by participants' health care providers.
|
Standard of Care
n=51 Participants
Participants will receive standard of care only.
Standard of Care: Fatigue management provided by participants' health care providers.
|
|---|---|---|---|
|
Change in Quality of Life at Week 6
Baseline
|
9.32 mean score
Interval 8.33 to 10.31
|
9.73 mean score
Interval 8.77 to 10.7
|
8.59 mean score
Interval 7.58 to 9.6
|
|
Change in Quality of Life at Week 6
Week 6
|
8.26 mean score
Interval 7.2 to 9.33
|
9.31 mean score
Interval 8.28 to 10.33
|
8.67 mean score
Interval 7.65 to 9.69
|
SECONDARY outcome
Timeframe: Baseline up to week 24Population: Number of evaluable patients at 24 weeks
Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O). The FACT-O is a questionnaire used to assess the quality of life in women with ovarian cancer. It includes 7 items, each scored from 0 to 4, with higher scores representing a more positive quality of life. Mean scores are reported by arm and timepoint. score range of 0-28.
Outcome measures
| Measure |
Acupressure Plus Standard of Care
n=37 Participants
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Acupressure: Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
Standard of Care: Fatigue management provided by participants' health care providers.
|
Sham Acupressure Plus Standard of Care
n=40 Participants
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Sham acupressure: Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
Standard of Care: Fatigue management provided by participants' health care providers.
|
Standard of Care
n=45 Participants
Participants will receive standard of care only.
Standard of Care: Fatigue management provided by participants' health care providers.
|
|---|---|---|---|
|
Change in Quality of Life up to Week 24
Baseline
|
9.32 mean score
Interval 8.33 to 10.31
|
9.73 mean score
Interval 8.77 to 10.7
|
8.59 mean score
Interval 7.58 to 9.6
|
|
Change in Quality of Life up to Week 24
Week 24
|
8.06 mean score
Interval 6.97 to 9.15
|
8.58 mean score
Interval 7.53 to 9.62
|
8.16 mean score
Interval 7.12 to 9.19
|
SECONDARY outcome
Timeframe: Baseline to week 6Population: evaluable patients at 6 weeks
Self-reported on the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) yields a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
Outcome measures
| Measure |
Acupressure Plus Standard of Care
n=40 Participants
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Acupressure: Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
Standard of Care: Fatigue management provided by participants' health care providers.
|
Sham Acupressure Plus Standard of Care
n=45 Participants
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Sham acupressure: Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
Standard of Care: Fatigue management provided by participants' health care providers.
|
Standard of Care
n=50 Participants
Participants will receive standard of care only.
Standard of Care: Fatigue management provided by participants' health care providers.
|
|---|---|---|---|
|
Change in Sleep Quality at Week 6
Baseline
|
9.32 mean score
Interval 8.33 to 10.31
|
9.73 mean score
Interval 8.77 to 10.7
|
8.59 mean score
Interval 7.58 to 9.6
|
|
Change in Sleep Quality at Week 6
Week 6
|
8.26 mean score
Interval 7.2 to 9.33
|
9.31 mean score
Interval 8.28 to 10.33
|
8.67 mean score
Interval 7.65 to 9.69
|
SECONDARY outcome
Timeframe: Baseline up to week 24Population: evaluable patients at 24 weeks
Self-reported on the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) yields a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
Outcome measures
| Measure |
Acupressure Plus Standard of Care
n=37 Participants
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Acupressure: Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
Standard of Care: Fatigue management provided by participants' health care providers.
|
Sham Acupressure Plus Standard of Care
n=40 Participants
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Sham acupressure: Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
Standard of Care: Fatigue management provided by participants' health care providers.
|
Standard of Care
n=45 Participants
Participants will receive standard of care only.
Standard of Care: Fatigue management provided by participants' health care providers.
|
|---|---|---|---|
|
Change in Sleep Quality up to Week 24
Week 24
|
8.06 mean score
Interval 6.97 to 9.15
|
8.58 mean score
Interval 7.53 to 9.62
|
8.16 mean score
Interval 7.12 to 9.19
|
|
Change in Sleep Quality up to Week 24
Baseline
|
9.32 mean score
Interval 8.33 to 10.31
|
9.73 mean score
Interval 8.77 to 10.7
|
8.59 mean score
Interval 7.58 to 9.6
|
Adverse Events
Acupressure Plus Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Acupressure Plus Standard of Care
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acupressure Plus Standard of Care
n=53 participants at risk
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Acupressure: Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
Standard of Care: Fatigue management provided by participants' health care providers.
|
Sham Acupressure Plus Standard of Care
n=56 participants at risk
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Sham acupressure: Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
Standard of Care: Fatigue management provided by participants' health care providers.
|
Standard of Care
n=51 participants at risk
Participants will receive standard of care only.
Standard of Care: Fatigue management provided by participants' health care providers.
|
|---|---|---|---|
|
Infections and infestations
Guillain-Barré syndrome (GBS)
|
0.00%
0/53 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through the follow up visit at week 6.
|
1.8%
1/56 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through the follow up visit at week 6.
|
0.00%
0/51 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through the follow up visit at week 6.
|
Other adverse events
| Measure |
Acupressure Plus Standard of Care
n=53 participants at risk
Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
Acupressure: Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
Standard of Care: Fatigue management provided by participants' health care providers.
|
Sham Acupressure Plus Standard of Care
n=56 participants at risk
Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
Sham acupressure: Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
Standard of Care: Fatigue management provided by participants' health care providers.
|
Standard of Care
n=51 participants at risk
Participants will receive standard of care only.
Standard of Care: Fatigue management provided by participants' health care providers.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
rheumatoid arthritis
|
0.00%
0/53 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through the follow up visit at week 6.
|
1.8%
1/56 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through the follow up visit at week 6.
|
0.00%
0/51 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through the follow up visit at week 6.
|
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place