Fatigue Interventions in Cancer (Exercise Intervention)

Completed · Phase 2

Conditions studied: Sedentary Lifestyle, Stage III Prostate Cancer AJCC v7, Stage IV Prostate Cancer AJCC v7

In brief

This randomized pilot phase II trial studies how well exercise intervention with or without internet-based cognitive behavior therapy works in reducing fatigue in participants with prostate cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Exercise intervention and internet-based cognitive behavior therapy may help to improve feelings of tiredness in participants with prostate cancer. The study originally included both prostate cancer and breast cancer participants, but due to low accrual of breast cancer participants, the breast cancer cohort was closed and the study continued with prostate cancer participants only.

Key facts

Study ID

NCT03421782

Run by

University of Utah

People needed

126

Starts

2018-02-26

Expected to finish

2022-08-08

Last updated by the study team

2026-02-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with advanced prostate cancer
• Currently treated with hormone therapy-based regimen, including selective estrogen receptor modulators (SERMs), aromatase inhibitors, selective estrogen receptor down regulators (SERDs), CYP17A1 inhibitors, gonadotrophin releasing hormone (GnRH) agonists/antagonists, and antiandrogens; concurrent anti-HER2 therapy and other targeted therapy (e.g., CDK4/6 inhibitor, mTOR inhibitor) is permitted; must have started the current regimen at least 4 weeks prior to enrollment
• A response of at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired) to the question ?how tired did you feel in the past week??
• Sedentary activity pattern (Average < 90 minutes per week of moderate-to-vigorous intensity sports activity based on patient self-report) within the past year
• Physically able to exercise and physician consent to start an exercise program
• Regular access to a computer with internet service
• Must be able to read and understand English
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

You may not qualify if…

• Evidence of disease progression at the time of enrollment
• Treatment with cytotoxic chemotherapy within 3 months prior to enrollment
• Prior cognitive-behavioral therapy

Where it is running

• Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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