Prostate Cancer Clinical Trial

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

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.

View Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate
Age 60 years or older

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
Patient able to give informed consent.

Exclusion Criteria:

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

48

Study ID:

NCT01607879

Recruitment Status:

Completed

Sponsor:

Medical College of Wisconsin

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Froedtert Hospital and the Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

48

Study ID:

NCT01607879

Recruitment Status:

Completed

Sponsor:


Medical College of Wisconsin

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.