Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer

Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:April 1, 2017
End Date:March 31, 2019
Contact:Erik D Hanson, PhD

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Feasibility Study of a Home-Based Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)

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.

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)). Finally, the effects of the exercise training on
biomarkers of inflammation and hormonal status and their potential association with changes
in body composition, physical function, fatigue, depression, and QoL will be explored.

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.

- Ability to engage safely in moderate exercise as determined by their treating

- 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

- 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

- 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

- 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.
We found this trial at
101 Manning Drive
Chapel Hill, North Carolina 27514
(919) 966-0000
Phone: 919-962-0816
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill One of the...
Chapel Hill, NC
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Winston-Salem, North Carolina 27103
Winston-Salem, NC
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