Resistance Training and Protein Supplementation for Prostate Cancer Survivors

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: exercise intervention; Dietary Supplement: nutritional supplementation; Procedure: quality-of-life assessment; Other: questionnaire administration; Other: pharmacological study; Other: laboratory biomarker analysis

• Registration Number: NCT01909440
• Lead Sponsor: University of Southern California

Brief Summary

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

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 Timeline

• Study Start: 2013-07-08
• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-26
• Primary Completion: 2017-03-10
• Study Completion: 2018-08-07
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-17
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (total body RT)	pharmacological study	Patients undergo total body RT and stretching as in Arm I.
Arm II (total body RT)	exercise intervention	Patients undergo total body RT and stretching as in Arm I.
Arm III (protein supplementation)	laboratory biomarker analysis	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.
Arm I (RT + PS)	nutritional supplementation	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 I (RT + PS)	quality-of-life assessment	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 I (RT + PS)	laboratory biomarker analysis	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 (total body RT)	questionnaire administration	Patients undergo total body RT and stretching as in Arm I.
Arm IV (attention control)	questionnaire administration	Patients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I.
Arm II (total body RT)	quality-of-life assessment	Patients undergo total body RT and stretching as in Arm I.
Arm I (RT + PS)	questionnaire administration	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 III (protein supplementation)	nutritional supplementation	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.
Arm III (protein supplementation)	quality-of-life assessment	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.
Arm III (protein supplementation)	pharmacological study	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.
Arm I (RT + PS)	exercise intervention	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 I (RT + PS)	pharmacological study	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 (total body RT)	laboratory biomarker analysis	Patients undergo total body RT and stretching as in Arm I.
Arm III (protein supplementation)	questionnaire administration	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.
Arm IV (attention control)	quality-of-life assessment	Patients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I.
Arm IV (attention control)	pharmacological study	Patients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I.
Arm IV (attention control)	laboratory biomarker analysis	Patients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I.

Primary Outcome Measures

Name	Time	Method
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	Baseline up to 12 weeks	Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).
Change in strength	Baseline up to 12 weeks	Intent-to-treat models will be computed using repeated measures ANOVA.
Change in quality of life	Baseline up to 12 weeks	Intent-to-treat models will be computed using repeated measures ANOVA.

Trial Locations

Locations (1)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States