Status:
COMPLETED
Resistance Training and Protein Supplementation for Prostate Cancer Survivors
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
50+ years
Phase:
NA
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. Resis...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2018
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01909440
Start Date
July 8 2013
End Date
August 7 2018
Last Update
June 19 2019
Active Locations (1)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033