Prostate Cancer Clinical Trial
Official title:
Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
This randomized pilot clinical trial studies resistance training and protein supplementation in increasing lean body mass in patients with prostate cancer receiving androgen deprivation therapy. Resistance training and protein supplementation may help improve quality of life in patients with prostate cancer receiving androgen deprivation therapy.
PRIMARY OBJECTIVES:
I. To examine the effects of progressive, structured resistance training (RT) program , with
and without protein supplementation (PS), on lean body mass (LBM) in prostate cancer
survivors (PCS) on androgen deprivation therapy (ADT). Increases in LBM may influence
additional outcomes such as physical function, quality of life (QOL) and molecular pathways
that regulate skeletal muscle.
SECONDARY OBJECTIVES:
I. To examine the effects of a structured RT program, with and without PS, on muscle
strength, physical function, and QOL in PCS on ADT .
TERTIARY OBJECTIVES:
I. To examine the effects of a progressive, structured RT program, with and without PS, on
anabolic and catabolic molecular regulators of skeletal muscle in PCS on ADT.
II. To examine the effects of a progressive, structured RT program, with and without PS, on
bone turnover markers and bone mineral density in PCS on ADT.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients undergo total body high-intensity RT thrice weekly, and perform static
stretching exercises after each session. Exercises progress from low intensity and high
volume to higher intensity and lower volume over the course of the 12-week program. Patients
also receive whey protein supplementation orally twice a day for 12 weeks.
ARM II: Patients undergo total body RT and stretching as in Arm I.
ARM III: Patients receive whey protein supplementation as in Arm I. Patients also undergo a
home flexibility program 3 times per week, consisting of the same static stretching exercises
performed after RT. After 12 weeks, may undergo the RT program as in Arm 1.
ARM IV: Patients undergo the home flexibility program as in Arm III. After 12 weeks, patient
may undergo total body RT as in Arm 1.
After completion of study treatment, patients are followed up periodically.
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