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Exercise and Whey Protein Supplementation as Adjunctive Therapy for Patients With Prostate Cancer Receiving Androgen Deprivation Therapy

Description

PRIMARY OBJECTIVES: I. To determine feasibility of conducting a resistance training (RT) and supplementation program in this population, determine patient adherence and inter-patient variability, and estimate the necessary effect sizes for a larger study. SECONDARY OBJECTIVES: I. To examine the effects of a high intensity RT program, with and without whey protein supplement (WPS), on lean body mass (LBM). Enhancing LBM will increase muscle strength, endurance, and physical function leading to improved quality of life. TERTIARY OBJECTIVES: I. To examine the effects of a high intensity RT program with and without WPS on muscle strength, endurance, physical function, and quality of life. II. To examine changes in lymphocyte glutathione (GSH) and the pharmacodynamics of WPS with and without high intensity RT. OUTLINE: Patients are randomized to 1 of 4 arms. ARM I: Patients receive whole body high-intensity RT thrice weekly and whey protein supplementation orally (PO) daily for 12 weeks. ARM II: Patients receive whole body RT as in Arm I. ARM III: Patients receive whey protein supplementation as in Arm I. ARM IV: Patients receive no intervention for 12 weeks. After 12 weeks, patients may receive whole body RT as in Arm II. After completion of study treatment, patients are followed up periodically.

Phase

N/A

Inclusion and Exclusion 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

  • 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

Sites

  • California

    • USC Norris Comprehensive Cancer Center, Los Angeles, California, 90033
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