- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03763838
Acupressure for Fatigue in Ovarian Cancer Survivors
January 19, 2026 updated by: University of Michigan Rogel Cancer Center
The purpose of this study is to see if accupressure can help reduce the severity of fatigue experienced by ovarian cancer patients.
Acupressure involves applying mild to moderate physical pressure by fingers, hand or a device to specific points on the skin to try to bring about a change in the body's functioning, in this case relief from chronic fatigue.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
171
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Rogel Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women aged 21 and older
- Diagnosis of ovarian cancer, stages I to IV
- Have average persistent fatigue defined a >=4 on the Brief Fatigue Inventory.
- Fatigue must have started at or after the diagnosis of ovarian cancer
- Completed all primary cancer treatments (surgery, chemotherapy at least 6 months prior), except maintenance therapies
- No other planned interventions for fatigue other than current stable medication
Exclusion Criteria:
- Medically unstable
- Acupuncture or acupressure receipt in past year
- Have a diagnosis of untreated mood disorder, e.g., bipolar or major depressive disorder
- Have a current diagnosis of anemia
- Have a current untreated diagnosis of hypothyroidism
- Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy, etc., or any planned change of medications, supplements or therapies during the study
- Have the possibility of becoming pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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).
Fatigue management provided by participants' health care providers.
|
|
Sham Comparator: 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.
|
Fatigue management provided by participants' health care providers.
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.
|
|
Other: Standard of care
Participants will receive standard of care only.
|
Fatigue management provided by participants' health care providers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Level of Fatigue at Week 6
Time Frame: Baseline to 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.
|
Baseline to week 6
|
|
Change in Level of Fatigue up to Week 24
Time Frame: Baseline up to week 24
|
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.
|
Baseline up to week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of Life at Week 6
Time Frame: Baseline to week 6
|
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.
|
Baseline to week 6
|
|
Change in Quality of Life up to Week 24
Time Frame: Baseline up to week 24
|
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.
|
Baseline up to week 24
|
|
Change in Sleep Quality at Week 6
Time Frame: Baseline to week 6
|
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.
|
Baseline to week 6
|
|
Change in Sleep Quality up to Week 24
Time Frame: Baseline up to week 24
|
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.
|
Baseline up to week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Suzanna M Zick, ND, MPH, University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2019
Primary Completion (Actual)
June 18, 2024
Study Completion (Actual)
June 18, 2024
Study Registration Dates
First Submitted
December 3, 2018
First Submitted That Met QC Criteria
December 3, 2018
First Posted (Actual)
December 4, 2018
Study Record Updates
Last Update Posted (Actual)
February 5, 2026
Last Update Submitted That Met QC Criteria
January 19, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Ovarian Neoplasms
- Fatigue
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Therapeutics
- Quality of Health Care
- Complementary Therapies
- Physical Therapy Modalities
- Quality Indicators, Health Care
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Standard of Care
- Acupressure
Other Study ID Numbers
- UMCC 2018.130
- HUM00143509 (Other Identifier: University of Michigan)
- W81XWH1810180 (Other Grant/Funding Number: Defense, Department of-Army, Department of the)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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