Acupressure for Fatigue in Ovarian Cancer Survivors

NCT03763838 | Completed Results

• 3 other identifiers: UMCC 2018.130HUM00143509W81XWH1810180
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue; Ovarian Cancer

Keywords

Acupressure

Outcome Measures

Primary Outcomes (2)

• Change in Level of Fatigue 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.

  Baseline to week 6

• Change in Level of Fatigue 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 Outcomes (4)

• Change in Quality of Life at Week 6

  Baseline to week 6

• Change in Quality of Life up to Week 24

  Baseline up to week 24

• Change in Sleep Quality at Week 6

  Baseline to week 6

• Change in Sleep Quality up to Week 24

  Baseline up to week 24

Study Arms (3)

Acupressure plus standard of care

EXPERIMENTAL

Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.

Other: Acupressure; Other: Standard of Care

Sham acupressure plus standard of care

SHAM COMPARATOR

Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.

Other: Sham acupressure; Other: Standard of Care

Standard of care

OTHER

Participants will receive standard of care only.

Other: Standard of Care

Interventions

Acupressure OTHER

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).

Acupressure plus standard of care

Sham acupressure OTHER

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.

Sham acupressure plus standard of care

Standard of Care OTHER

Fatigue management provided by participants' health care providers.

Acupressure plus standard of care; Sham acupressure plus standard of care; Standard of care

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• Zick SM, Chen D, Harris RE, Kruger G, Runyon A, Sen A, Snyder S, Pearce CL. Self-Acupressure for Fatigue in Patients Surviving Ovarian Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2556357. doi: 10.1001/jamanetworkopen.2025.56357.

  PMID: 41642626 DERIVED

• Zick SM, Kruger G, Harte S, Sen A, Harris RE, Pearce CL. Acupressure for Cancer-fatigue in Ovarian Cancer Survivor (AcuOva) Study: A community-based clinical trial study protocol examining the impact of self-acupressure on persistent cancer-related fatigue in ovarian cancer survivors. Contemp Clin Trials. 2021 Aug;107:106477. doi: 10.1016/j.cct.2021.106477. Epub 2021 Jun 10.

  PMID: 34119716 DERIVED

MeSH Terms

Conditions

Fatigue; Ovarian Neoplasms

Interventions

Acupressure; Standard of Care

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
• Organization: University of Michigan Rogel Cancer Center

ClinicalTrialsgov_CCAdmin@umich.edu

734-936-9499

Study Officials

• Suzanna M Zick, ND, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants in the "standard of care" arm will not be blinded; however, the two self-acupressure arms will be blinded as to which acupressure treatment they have been randomized. All study staff and researchers will remain blinded until after the completion of data analyses.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: October 7, 2019
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: February 5, 2026
• Results First Posted: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)