We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01909440
Previous Study | Return to List | Next Study

Resistance Training and Protein Supplementation for Prostate Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01909440
First Posted: July 26, 2013
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exercise and Protein Supplementation for Prostate Cancer Survivors Receiving Androgen Deprivation Therapy

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Completion of the resistance training program with at least 80% of the sessions attended [ Time Frame: 12 weeks ]
  • Compliance with protein supplementation [ Time Frame: 12 weeks ]
  • Change in lean body mass [ Time Frame: Baseline up to 12 weeks ]
    Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).

  • Change in strength [ Time Frame: Baseline up to 12 weeks ]
    Intent-to-treat models will be computed using repeated measures ANOVA.

  • Change in quality of life [ Time Frame: Baseline up to 12 weeks ]
    Intent-to-treat models will be computed using repeated measures ANOVA.


Enrollment: 41
Actual Study Start Date: July 8, 2013
Estimated Study Completion Date: July 8, 2019
Estimated Primary Completion Date: July 8, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: exercise intervention
Receive whole body RT
Dietary Supplement: nutritional supplementation
Given whey protein supplementation PO
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (total body RT)
Patients undergo total body RT and stretching as in Arm I.
Behavioral: exercise intervention
Receive whole body RT
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Experimental: 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.
Dietary Supplement: nutritional supplementation
Given whey protein supplementation PO
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Active Comparator: 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.
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909440


Locations
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: E. Todd Schroeder University of Southern California
  More Information

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01909440     History of Changes
Other Study ID Numbers: 4P-13-2
NCI-2013-01360 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HS-13-00315
P30CA014089 ( U.S. NIH Grant/Contract )
First Submitted: July 24, 2013
First Posted: July 26, 2013
Last Update Posted: May 2, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases