drugset / Trial / NCT01607879

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

NCT01607879 ↗

Phase 2 Completed 48 enrolled Medical College of Wisconsin
RandomizedParallel-groupOpen-labelSupportive care

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.

Timeline

Start
2014-03
Primary completion
2018-07
Completion
2021-02-16

Outcome

Missed primary endpoint

registry analysis (superiority test); Standard of Care ADT + (HMB + AG) vs Standard of Care ADT; p = 0.1497; t-test, 1 sided NCT01607879 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Arginine Other / unclassified 7 g —
Subject Glutamine Other / unclassified 7 g —
Subject β-hydroxy-β-methylbutyrate Unknown 1.5 g —

Indications