Resistance Training and Protein Supplementation for Prostate Cancer Survivors
NCT ID: NCT01909440
Last Updated: 2019-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2013-07-08
2018-08-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
exercise intervention
Receive whole body RT
nutritional supplementation
Given whey protein supplementation PO
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies
Arm II (total body RT)
Patients undergo total body RT and stretching as in Arm I.
exercise intervention
Receive whole body RT
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies
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.
nutritional supplementation
Given whey protein supplementation PO
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies
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.
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies
Interventions
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exercise intervention
Receive whole body RT
nutritional supplementation
Given whey protein supplementation PO
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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E. Todd Schroeder
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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References
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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.
Other Identifiers
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NCI-2013-01360
Identifier Type: REGISTRY
Identifier Source: secondary_id
HS-13-00315
Identifier Type: -
Identifier Source: secondary_id
4P-13-2
Identifier Type: -
Identifier Source: org_study_id
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