Clinical trial NCT01607879: Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Men
Androgen Deprivation Therapy
Elderly
Geriatric
Nutritional supplementation
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 48
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 criteria: Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate
2. Age 60 years or older
3. Patients with asymptomatic or minimally symptomatic prostate cancer 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)

Primary outcomes:
measure: Change From Baseline in Body Composition (Lean Body Mass)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change From Baseline of Dorsiflexor Muscle Size in mm^2.
timeFrame: Baseline and 3 months
measure: Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms.
timeFrame: Baseline and 3 months
measure: Physical Performance Measured Using the Short Physical Performance Battery (SPPB)
timeFrame: Baseline and 3 months
measure: Change From Baseline in the Number of Fall Events
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Kathryn Bylow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.