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Use of β-hydroxy-β-methylbutyrate to Counteract Loss of Muscle Mass and Strength in Older Men With Recurrent Prostate Cancer Started on Androgen Deprivation Therapy


Phase 2
65 Years
N/A
Not Enrolling
Male
Recurrent Prostate Cancer

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Trial Information

Use of β-hydroxy-β-methylbutyrate to Counteract Loss of Muscle Mass and Strength in Older Men With Recurrent Prostate Cancer Started on Androgen Deprivation Therapy


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.


Inclusion Criteria:



1. Histologically confirmed adenocarcinoma of the prostate

2. Age 65 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 metastases 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Prospectively measure the change in body composition in older men with prostate cancer (PCa) recurrence starting on ADT, comparing those who receive HMB + AG versus those who do not.

Outcome Time Frame:

Baseline and 3 months

Safety Issue:

No

Principal Investigator

Kathryn Bylow, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin

Authority:

United States: Food and Drug Administration

Study ID:

00016781

NCT ID:

NCT01607879

Start Date:

May 2013

Completion Date:

October 2014

Related Keywords:

  • Recurrent Prostate Cancer
  • Prostate Cancer
  • Men
  • Androgen Deprivation Therapy
  • Elderly
  • Geriatric
  • Nutritional supplementation
  • Prostatic Neoplasms

Name

Location

Medical College of WisconsinMilwaukee, Wisconsin  53226