Resistance Training and Protein Supplementation for Prostate Cancer Survivors

University of Southern California

Status

Completed

Conditions

Prostate Cancer

Treatments

Behavioral: exercise intervention

Dietary Supplement: nutritional supplementation

Other: questionnaire administration

Other: laboratory biomarker analysis

Other: pharmacological study

Procedure: quality-of-life assessment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01909440

HS-13-00315

4P-13-2

P30CA014089 (U.S. NIH Grant/Contract)

NCI-2013-01360 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

43 participants in 4 patient groups

Arm I (RT + PS)

Experimental group

Description:

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.

Treatment:

Other: laboratory biomarker analysis

Behavioral: exercise intervention

Dietary Supplement: nutritional supplementation

Other: questionnaire administration

Procedure: quality-of-life assessment

Other: pharmacological study

Arm II (total body RT)

Experimental group

Description:

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

Treatment:

Other: laboratory biomarker analysis

Behavioral: exercise intervention

Other: questionnaire administration

Procedure: quality-of-life assessment

Other: pharmacological study

Arm III (protein supplementation)

Experimental group

Description:

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.

Treatment:

Other: laboratory biomarker analysis

Dietary Supplement: nutritional supplementation

Other: questionnaire administration

Procedure: quality-of-life assessment

Other: pharmacological study

Arm IV (attention control)

Active Comparator group

Description:

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

Treatment:

Other: laboratory biomarker analysis