Prostate Cancer Clinical Trial

Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer

Summary

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.

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Full Description

The purpose of this trial is to evaluate the feasibility and adherence to a home-based 12 week exercise intervention in mCRPC patients receiving ADT. It will also examine if a home-based exercise intervention can improve muscle strength, body composition, physical function, cardiopulmonary function fatigue, and patient reported outcomes (fatigue, depression, quality of life (QoL)).

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Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

22

Study ID:

NCT03672396

Recruitment Status:

Completed

Sponsor:

UNC Lineberger Comprehensive Cancer Center

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There are 2 Locations for this study

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Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill North Carolina, 27599, United States
Comprehensive Cancer Center, Wake Forest Baptist Health
Winston-Salem North Carolina, 27103, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

22

Study ID:

NCT03672396

Recruitment Status:

Completed

Sponsor:


UNC Lineberger Comprehensive Cancer Center

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