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Completed

NCT Number: NCT03763838

Acupressure for Fatigue in Ovarian Cancer Survivors

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Standard of care

Other

Fatigue management provided by participants' health care providers.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2018
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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