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

NCT01607879 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-09-22

Study results available
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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.

Conditions

Interventions

DRUG

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

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

OTHER

Standard of care ADT

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

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Kathryn Bylow, MD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-07-31
Completion
2021-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01607879 on ClinicalTrials.gov