Trial record 1 of 1 for:    NCT01909440
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Resistance Training and Whey Protein Supplementation in Increasing Lean Body Mass in Patients With Prostate Cancer Receiving Androgen Deprivation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Southern California
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01909440
First received: July 24, 2013
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

This randomized pilot clinical trial studies resistance training and whey protein supplementation in increasing lean body mass in patients with prostate cancer receiving androgen deprivation therapy. Resistance training and whey 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Exercise and Whey Protein Supplementation as Adjunctive Therapy for Patients With Prostate Cancer 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 ] [ Designated as safety issue: No ]
  • Compliance with protein supplementation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in lean body mass [ Time Frame: Baseline up to 12 weeks ] [ Designated as safety issue: No ]
    Intent-to-treat models will be computed using repeated measures analysis of variance (ANOVA).

  • Change in strength [ Time Frame: Baseline up to 12 weeks ] [ Designated as safety issue: No ]
    Intent-to-treat models will be computed using repeated measures ANOVA.

  • Change in quality of life [ Time Frame: Baseline up to 12 weeks ] [ Designated as safety issue: No ]
    Intent-to-treat models will be computed using repeated measures ANOVA.


Estimated Enrollment: 32
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (whole body RT and whey protein supplementation)
Patients receive whole body high-intensity RT thrice weekly and whey protein supplementation PO daily 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 (whole body RT)
Patients receive whole body RT 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 (whey protein supplementation)
Patients receive whey protein supplementation 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
No Intervention: Arm IV (control)
Patients receive no intervention for 12 weeks. After 12 weeks, patients may receive whole body RT as in Arm II.

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine feasibility of conducting a resistance training (RT) and supplementation program in this population, determine patient adherence and inter-patient variability, and estimate the necessary effect sizes for a larger study.

SECONDARY OBJECTIVES:

I. To examine the effects of a high intensity RT program, with and without whey protein supplement (WPS), on lean body mass (LBM). Enhancing LBM will increase muscle strength, endurance, and physical function leading to improved quality of life.

TERTIARY OBJECTIVES:

I. To examine the effects of a high intensity RT program with and without WPS on muscle strength, endurance, physical function, and quality of life.

II. To examine changes in lymphocyte glutathione (GSH) and the pharmacodynamics of WPS with and without high intensity RT.

OUTLINE: Patients are randomized to 1 of 4 arms. ARM I: Patients receive whole body high-intensity RT thrice weekly and whey protein supplementation orally (PO) daily for 12 weeks.

ARM II: Patients receive whole body RT as in Arm I.

ARM III: Patients receive whey protein supplementation as in Arm I.

ARM IV: Patients receive no intervention for 12 weeks. After 12 weeks, patients may receive whole body RT as in Arm II.

After completion of study treatment, patients are followed up periodically.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909440

Locations
United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: E. Todd Schroeder    323-442-2498    eschroed@usc.edu   
Principal Investigator: E. Todd Schroeder         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: E. Todd Schroeder University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01909440     History of Changes
Other Study ID Numbers: 4P-13-2, NCI-2013-01360, HS-13-00315, P30CA014089
Study First Received: July 24, 2013
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014