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

NCT01607879 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 00016781
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

Prostate Cancer; Men; Androgen Deprivation Therapy; Elderly; Geriatric; Nutritional supplementation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Body Composition (Lean Body Mass)

  This measure will be the change of lean body mass from baseline reported in kilograms.

  Baseline, 3 months

Secondary Outcomes (4)

• Change From Baseline of Dorsiflexor Muscle Size in mm^2.

  Baseline and 3 months

• Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms.

  Baseline and 3 months

• Physical Performance Measured Using the Short Physical Performance Battery (SPPB)

  Baseline and 3 months

• Change From Baseline in the Number of Fall Events

  Baseline, 3 months

Study Arms (2)

Standard of care ADT + (HMB + AG)

EXPERIMENTAL

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

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

Standard of care ADT

ACTIVE COMPARATOR

Standard of care androgen deprivation therapy

Other: Standard of care ADT

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

Also known as: Juven

Standard of care ADT + (HMB + AG)

Standard of care ADT OTHER

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

Also known as: Standard of care androgen deprivation therapy (ADT)

Standard of care ADT

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.

  PMID: 10811152 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Multiple Endocrine Neoplasia Type 1

Interventions

Arginine; Glutamine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Amino Acids, Neutral

Results Point of Contact

• Title: Kathryn Bylow, MD
• Organization: Froedtert and the Medical college of Wisconsin

kbylow@mcw.edu

414-805-4600

Study Officials

• Kathryn Bylow, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: May 30, 2012
• Study Start: March 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: February 16, 2021
• Last Updated: September 22, 2023
• Results First Posted: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)