CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Standard of care ADT + (HMB + arginine + glutamine) +1 moredrug
Likely dose
Standard of care ADT + (HMB + arginine + glutamine) 1.5 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01607879
NCT01607879Phase 2Completed
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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

Medical College of Wisconsin·interventional·Posted May 30, 2012·Updated Sep 22, 2023

In Brief

A Phase 2 clinical trial evaluating Standard of care ADT + (HMB + arginine + glutamine) and Standard of care ADT for Prostate Cancer. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 30, 2012
Enrollment StartMar 1, 2014
Primary CompletionJul 1, 2018
Study CompletionFeb 16, 2021
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 14.1 years ago

Interventions

Standard of care ADT + (HMB + arginine + glutamine)drug

1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine. Take one packet twice daily for 3 months

Standard of care ADTother

Patient will receive standard of care androgen deprivation therapy (ADT) alone