Resistance Training and Protein Supplementation for Prostate Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: exercise intervention
* Dietary Supplement: nutritional supplementation
* Procedure: quality-of-life assessment
* Other: questionnaire administration
* Other: pharmacological study
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with prostate cancer Treatment with androgen deprivation therapy (ADT) (gonadotropin-releasing hormone [GnRH] agonist/antagonist with or without anti-androgen) for prostate cancer Receiving ADT for a minimum of 12 weeks before enrollment into the study Planned ADT for the duration of the 12-week study period Asymptomatic, or minimally symptomatic from prostate cancer or prostate cancer related therapies No opioid-requiring cancer related pain Any therapy related genitourinary or gastrointestinal symptoms should be considered as mild (Common Terminology Criteria for Adverse Events [CTCAE] grade 1 or 2) and not interfering with activities of daily living Permission from treating/study physician to participate in RT Exclusion Criteria: No concurrent use of chemotherapy or radiotherapy (radiotherapy should be completed at least 4 weeks from study entry) History of allergic reactions to whey protein Milk protein intolerance/allergies (lactose intolerance is acceptable) Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements Recovered from major surgery within the last 6 months Acute coronary (e.g. myocardial infarction) or vascular event within the last year as well as uncontrolled coronary heart disease (e.g. progressive angina) Stroke within the past 2 years Neurologic and/or orthopedic limitations that preclude the participation in the training program (e.g. bone metastases that may pose a high risk of pathologic fracture) Subjects currently participating in a RT program

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (RT + PS)<br>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. | Behavioral: exercise intervention<br>* Receive whole body RT<br>Dietary Supplement: nutritional supplementation<br>* Given whey protein supplementation PO<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>Other: pharmacological study<br>* Correlative studies<br>* Other names: pharmacological studies;Other: laboratory biomarker analysis<br>* Correlative studies<br>|
| Experimental: Arm II (total body RT)<br>Patients undergo total body RT and stretching as in Arm I. | Behavioral: exercise intervention<br>* Receive whole body RT<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>Other: pharmacological study<br>* Correlative studies<br>* Other names: pharmacological studies;Other: laboratory biomarker analysis<br>* Correlative studies<br>|
| Experimental: Arm III (protein supplementation)<br>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, patients may undergo the RT program as in Arm I. | Dietary Supplement: nutritional supplementation<br>* Given whey protein supplementation PO<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>Other: pharmacological study<br>* Correlative studies<br>* Other names: pharmacological studies;Other: laboratory biomarker analysis<br>* Correlative studies<br>|
| Active Comparator: Arm IV (attention control)<br>Patients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I. | Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>Other: pharmacological study<br>* Correlative studies<br>* Other names: pharmacological studies;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of the resistance training program with at least 80% of the sessions attended |  | 12 weeks | 
| Compliance with protein supplementation |  | 12 weeks | 
| Change in lean body mass | Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA). | Baseline up to 12 weeks | 
| Change in strength | Intent-to-treat models will be computed using repeated measures ANOVA. | Baseline up to 12 weeks | 
| Change in quality of life | Intent-to-treat models will be computed using repeated measures ANOVA. | Baseline up to 12 weeks |