Prostate Cancer Clinical Trial

Resistance Training and Protein Supplementation for Prostate Cancer Survivors

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

43

Study ID:

NCT01909440

Recruitment Status:

Completed

Sponsor:

University of Southern California

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There is 1 Location for this study

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USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

43

Study ID:

NCT01909440

Recruitment Status:

Completed

Sponsor:


University of Southern California

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