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

Medical College of Wisconsin

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Other: Standard of care ADT; Drug: Standard of care ADT + (HMB + arginine + glutamine)

Study type: Interventional

Funder types: Other

Identifiers

NCT01607879

00016781

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: Male

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Standard of care ADT + (HMB + AG)

Experimental group

Description:

Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)

Treatment:

Drug: Standard of care ADT + (HMB + arginine + glutamine)

Standard of care ADT

Active Comparator group

Description:

Standard of care androgen deprivation therapy

Treatment:

Other: Standard of care ADT