Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer

Completed · Not applicable

Conditions studied: Castration-resistant Prostate Cancer, Androgen Deprivation Therapy

In brief

This single arm, multi-site pilot study aims to evaluate the feasibility of recruiting and adherence to a 12 week home-based exercise intervention to be conducted in men with metastatic castration resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Thirty patients will be enrolled, with the expectation that 20-25 will complete all follow-up measures.

Key facts

Study ID

NCT03672396

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

22

Starts

2017-04-01

Expected to finish

2019-12-31

Last updated by the study team

2021-04-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of < 50 ng/dL) receiving ADT. This will be verified by assessing total testosterone levels within 4 weeks prior to enrollment.
• No current chemotherapy.
• Patients may be receiving additional hormonal therapy agents including but not limited to antiandrogens (e.g. bicalutamide, enzalutamide) and CYP17 inhibitors (e.g. abiraterone).
• Ability to engage safely in moderate exercise as determined by their treating physician.
• Not previously engaged in regular exercise training (<3 or more d/wk for > 30 min/d or <90 mins per week total including strength training, aerobic training, or walking) in the past 6 months.
• Access to a computer or a smart phone for syncing and uploading wearable activity data.
• Be able to speak and read English.

You may not qualify if…

• Any condition that causes severe pain with exertion.
• History of bone fractures.
• Active cardiovascular disease including any of the following:
• New York Heart Association (NYHA) Grade II or greater congestive heart failure .
• History of myocardial infarction or unstable angina within 6 months prior to Day 1.
• History of stroke or transient ischemic attack within 6 months prior to Day 1.
• Acute or chronic respiratory disease that is severe enough to compromise the ability of the participant to safely engage in exercise training protocol.
• Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise.
• Neurological conditions that affect balance and, or muscle strength.
• Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent.

Where it is running

• Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States
• Comprehensive Cancer Center, Wake Forest Baptist Health — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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