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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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.
Baseline and 3 months
No
Kathryn Bylow, MD
Principal Investigator
Medical College of Wisconsin
United States: Food and Drug Administration
00016781
NCT01607879
May 2013
October 2014
Name | Location |
---|---|
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |