Resistance Training and Protein Supplementation for Prostate Cancer Survivors

NCT01909440 | Completed DMC

• 4 other identifiers: 4P-13-2NCI-2013-01360HS-13-00315P30CA014089
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• Completion of the resistance training program with at least 80% of the sessions attended

  12 weeks

• Compliance with protein supplementation

  12 weeks

• Change in lean body mass

  Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).

  Baseline up to 12 weeks

• Change in strength

  Intent-to-treat models will be computed using repeated measures ANOVA.

  Baseline up to 12 weeks

• Change in quality of life

  Intent-to-treat models will be computed using repeated measures ANOVA.

  Baseline up to 12 weeks

Study Arms (4)

Arm I (RT + PS)

EXPERIMENTAL

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.

Behavioral: exercise intervention; Dietary Supplement: nutritional supplementation; Procedure: quality-of-life assessment; Other: questionnaire administration; Other: pharmacological study; Other: laboratory biomarker analysis

Arm II (total body RT)

EXPERIMENTAL

Patients undergo total body RT and stretching as in Arm I.

Behavioral: exercise intervention; Procedure: quality-of-life assessment; Other: questionnaire administration; Other: pharmacological study; Other: laboratory biomarker analysis

Arm III (protein supplementation)

EXPERIMENTAL

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.

Dietary Supplement: nutritional supplementation; Procedure: quality-of-life assessment; Other: questionnaire administration; Other: pharmacological study; Other: laboratory biomarker analysis

Arm IV (attention control)

ACTIVE COMPARATOR

Patients undergo the home flexibility program as in Arm III. After 12 weeks, patients may undergo total body RT as in Arm I.

Procedure: quality-of-life assessment; Other: questionnaire administration; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

exercise intervention BEHAVIORAL

Receive whole body RT

Arm I (RT + PS); Arm II (total body RT)

nutritional supplementation DIETARY_SUPPLEMENT

Given whey protein supplementation PO

Arm I (RT + PS); Arm III (protein supplementation)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I (RT + PS); Arm II (total body RT); Arm III (protein supplementation); Arm IV (attention control)

questionnaire administration OTHER

Ancillary studies

Arm I (RT + PS); Arm II (total body RT); Arm III (protein supplementation); Arm IV (attention control)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I (RT + PS); Arm II (total body RT); Arm III (protein supplementation); Arm IV (attention control)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (RT + PS); Arm II (total body RT); Arm III (protein supplementation); Arm IV (attention control)

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Related Publications (3)

• 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.

  PMID: 34301165 DERIVED

• 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.

  PMID: 29614993 DERIVED

• 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.

  PMID: 28698349 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• E. Todd Schroeder

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Study Start: July 8, 2013
• Primary Completion: March 10, 2017
• Study Completion: August 7, 2018
• Last Updated: June 19, 2019

Record last verified: 2019-06

Locations

US (1)