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Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Medical College of Wisconsin
Sponsor:
Information provided by (Responsible Party):
Kathryn A Bylow, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01607879
First received: April 20, 2012
Last updated: April 6, 2016
Last verified: April 2016
  Purpose
This is a study of HMB plus amino acids in older men with prostate cancer starting androgen deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional supplementation will decrease the loss of muscle mass and strength that occurs when men start ADT.

Condition Intervention Phase
Prostate Cancer
Drug: Standard of care ADT + (HMB + arginine + glutamine)
Other: Standard of care ADT
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Use of β-hydroxy-β-methylbutyrate to Counteract Loss of Muscle Mass and Strength in Older Men With Prostate Cancer Started on Androgen Deprivation Therapy

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Prospectively measure the change in body composition in older men with prostate cancer (PCa) starting on ADT, comparing those who receive HMB + AG versus those who do not. [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prospectively measure the fatiguability and muscle size using MRI/Phosphorus MRI spectroscopy (31P-MRS) in older men with PCa starting on ADT, comparing those who receive HMB + AG versus those who do not. [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Prospectively analyze muscle fiber cross sectional area and fiber type using muscle biopsy in a subset of men with PCa starting ADT, comparing those who receive HMB + AG versus those who do not. [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Prospectively measure the change in strength in older men with PCa starting on ADT, comparing those who receive HMB + AG versus those who do not. [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Prospectively measure the change in physical performance measures in older men with PCa starting on ADT, comparing those who receive HMB + AG versus those who do not. [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Prospectively measure the change in falls in older men with PCa starting on ADT, comparing those who receive HMB + AG versus those who do not. [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard of care ADT + (HMB + AG)
Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)
Drug: Standard of care ADT + (HMB + arginine + glutamine)

1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.

Take one packet twice daily for 3 months

Other Name: Juven
Active Comparator: Standard of care ADT
Standard of care androgen deprivation therapy
Other: Standard of care ADT
Patient will receive standard of care androgen deprivation therapy (ADT) alone
Other Name: Standard of care androgen deprivation therapy (ADT)

Detailed Description:
It is well established that older patients experience age-related loss of muscle mass and function (sarcopenia), presumably due to an imbalance of protein synthesis versus protein breakdown. In addition, studies have shown that men who start on ADT experience increased muscle protein breakdown and decreased synthesis. β-hydroxy-β-methylbutyrate (HMB), a leucine metabolite, has been shown to slow protein breakdown. When HMB is given with arginine and lysine (which support protein synthesis) in randomized trials, researchers have shown that elderly men and women who receive this nutritional supplementation experience improvement in fat-free mass, strength, functionality and protein synthesis when compared with controls. In addition, patients with advanced cancer who experienced weight loss of at least 5% have also been shown to benefit from HMB, with supplementation resulting in a significant increase of fat-free mass when compared to controls. Thus, it seems reasonable that older men with prostate cancer starting on ADT who experience lean muscle loss as a result of aging and ADT, may achieve some benefit from supplementation with HMB as well. Use of HMB in men with prostate cancer has not been reported.
  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the prostate
  2. Age 60 years or older
  3. Patients with asymptomatic or minimally symptomatic PCa for which they are about to start androgen deprivation therapy (ADT) per provider recommendation

    • Asymptomatic or minimally symptomatic (as judged by treating physician) metastases allowed
    • Men receiving ADT for localized prostate cancer are allowed
  4. Patient able to give informed consent.

Exclusion Criteria:

  1. Patient already on ADT
  2. Patients who are visiting clinic for a second opinion only
  3. Patients with a diagnosis of dementia
  4. Patients with a diagnosis of a neuromuscular disorder (i.e. multiple sclerosis)
  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: NCT01607879

Contacts
Contact: MCW Cancer Center Clinical Trials Office 414-805-8900 cccto@mcw.edu

Locations
United States, Wisconsin
Froedtert Hospital and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: MCW Cancer Center Clinical Trials Office    414-805-8900      
Principal Investigator: Kathryn Bylow, MD         
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Kathryn Bylow, MD Medical College of Wisconsin
  More Information

Responsible Party: Kathryn A Bylow, MD, Assistant Professor of Medicine, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01607879     History of Changes
Other Study ID Numbers: 00016781 
Study First Received: April 20, 2012
Last Updated: April 6, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Prostate Cancer
Men
Androgen Deprivation Therapy
Elderly
Geriatric
Nutritional supplementation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Ascorbic Acid
Estrogens, Conjugated (USP)
Methyltestosterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents

ClinicalTrials.gov processed this record on September 30, 2016