Resistance Training and Protein Supplementation for Prostate Cancer Survivors
Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- USC Norris Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (RT + PS)
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.
|
Correlative studies
Ancillary studies
Ancillary studies
Other Names:
Correlative studies
Other Names:
Receive whole body RT
Given whey protein supplementation PO
|
|
Experimental: Arm II (total body RT)
Patients undergo total body RT and stretching as in Arm I.
|
Correlative studies
Ancillary studies
Ancillary studies
Other Names:
Correlative studies
Other Names:
Receive whole body RT
|
|
Experimental: Arm III (protein 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.
|
Correlative studies
Ancillary studies
Ancillary studies
Other Names:
Correlative studies
Other Names:
Given whey protein supplementation PO
|
|
Active Comparator: Arm IV (attention control)
Patients undergo the home flexibility program as in Arm III.
After 12 weeks, patients may undergo total body RT as in Arm I.
|
Correlative studies
Ancillary studies
Ancillary studies
Other Names:
Correlative studies
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion of the resistance training program with at least 80% of the sessions attended
Time Frame: 12 weeks
|
12 weeks
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Compliance with protein supplementation
Time Frame: 12 weeks
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12 weeks
|
|
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Change in lean body mass
Time Frame: Baseline up to 12 weeks
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Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).
|
Baseline up to 12 weeks
|
|
Change in strength
Time Frame: Baseline up to 12 weeks
|
Intent-to-treat models will be computed using repeated measures ANOVA.
|
Baseline up to 12 weeks
|
|
Change in quality of life
Time Frame: Baseline up to 12 weeks
|
Intent-to-treat models will be computed using repeated measures ANOVA.
|
Baseline up to 12 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: E. Todd Schroeder, University of Southern California
Publications and helpful links
General Publications
- Dawson JK, Dorff TB, Tuzon C, Rice JC, Schroeder ET, Lane CJ, Gross ME, Dieli-Conwright CM. Effect of Periodized Resistance Training on Skeletal Muscle During Androgen Deprivation Therapy for Prostate Cancer: A Pilot Randomized Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211035442. doi: 10.1177/15347354211035442.
- Dawson JK, Dorff TB, Todd Schroeder E, Lane CJ, Gross ME, Dieli-Conwright CM. Impact of resistance training on body composition and metabolic syndrome variables during androgen deprivation therapy for prostate cancer: a pilot randomized controlled trial. BMC Cancer. 2018 Apr 3;18(1):368. doi: 10.1186/s12885-018-4306-9.
- Kiwata JL, Dorff TB, Todd Schroeder E, Salem GJ, Lane CJ, Rice JC, Gross ME, Dieli-Conwright CM. A pilot randomised controlled trial of a periodised resistance training and protein supplementation intervention in prostate cancer survivors on androgen deprivation therapy. BMJ Open. 2017 Jul 10;7(7):e016910. doi: 10.1136/bmjopen-2017-016910.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4P-13-2
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2013-01360 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- HS-13-00315
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