Clinical trial NCT01909440: Resistance Training and Protein Supplementation for Prostate Cancer Survivors
Official title: Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-07-26
Enrollment: 43
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. Resistance training and protein supplementation may help improve quality of life in patients with prostate cancer receiving androgen deprivation therapy.

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.

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

Primary outcomes:
measure: Completion of the resistance training program with at least 80% of the sessions attended
timeFrame: 12 weeks
measure: Compliance with protein supplementation
timeFrame: 12 weeks
measure: Change in lean body mass
timeFrame: Baseline up to 12 weeks
measure: Change in strength
timeFrame: Baseline up to 12 weeks
measure: Change in quality of life
timeFrame: Baseline up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: E. Todd Schroeder
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.