Resistance Training and Protein Supplementation for Prostate Cancer Survivors

Prostate Cancer Clinical Trial

Official title:

Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909440
• Other study ID #: 4P-13-2
• Secondary ID: NCI-2013-01360HS
• Status: Completed
• Phase: N/A
• Start date: July 8, 2013
• Est. completion date: August 7, 2018

Study information

• Verified date: June 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 7, 2018
• Est. primary completion date: March 10, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• exercise intervention
Receive whole body RT

Dietary Supplement:
• nutritional supplementation
Given whey protein supplementation PO

Procedure:
• quality-of-life assessment
Ancillary studies

Other:
• questionnaire administration
Ancillary studies
• pharmacological study
Correlative studies
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of the resistance training program with at least 80% of the sessions attended		12 weeks
Primary	Compliance with protein supplementation		12 weeks
Primary	Change in lean body mass	Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).	Baseline up to 12 weeks
Primary	Change in strength	Intent-to-treat models will be computed using repeated measures ANOVA.	Baseline up to 12 weeks
Primary	Change in quality of life	Intent-to-treat models will be computed using repeated measures ANOVA.	Baseline up to 12 weeks