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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
43
Receive whole body RT
Given whey protein supplementation PO
Ancillary studies
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Completion of the resistance training program with at least 80% of the sessions attended
Time frame: 12 weeks
Compliance with protein supplementation
Time frame: 12 weeks
Change in lean body mass
Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).
Time frame: Baseline up to 12 weeks
Change in strength
Intent-to-treat models will be computed using repeated measures ANOVA.
Time frame: Baseline up to 12 weeks
Change in quality of life
Intent-to-treat models will be computed using repeated measures ANOVA.
Time frame: Baseline up to 12 weeks
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