Acupressure for Fatigue in Ovarian Cancer Survivors

Ovarian Cancer Clinical Trial

Official title:

Acupressure for Fatigue in Ovarian Cancer Survivors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03763838
• Other study ID #: UMCC 2018.130
• Secondary ID: HUM00143509W81XW
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: June 18, 2024

Study information

• Verified date: June 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: June 18, 2024
• Est. primary completion date: June 18, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fatigue
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• 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).
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in level of fatigue at week 6	Self-reported on the Brief Fatigue Inventory (BFI)	Baseline to week 6
Primary	Change in level of fatigue up to week 24	Self-reported on the Brief Fatigue Inventory (BFI)	Baseline up to week 24
Secondary	Change in quality of life at week 6	Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)	Baseline to week 6
Secondary	Change in quality of life up to week 24	Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)	Baseline up to week 24
Secondary	Change in sleep quality at week 6	Self-reported on the Pittsburgh Sleep Quality Index (PSQI)	Baseline to week 6
Secondary	Change in sleep quality up to week 24	Self-reported on the Pittsburgh Sleep Quality Index (PSQI)	Baseline up to week 24