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

NCT ID: NCT01607879

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2021-02-16

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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of care ADT + (HMB + AG)

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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 ADT

Standard of care androgen deprivation therapy

Group Type: ACTIVE_COMPARATOR

Standard of care ADT

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DRUG

Standard of care ADT

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

Intervention Type: OTHER

Other Intervention Names

Juven; Standard of care androgen deprivation therapy (ADT)

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed adenocarcinoma of the prostate

2. Age 60 years or older

3. 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

4. Patient able to give informed consent.

Exclusion Criteria

1. Patient already on ADT

2. Patients who are visiting clinic for a second opinion only

3. Patients with a diagnosis of dementia

4. Patients with a diagnosis of a neuromuscular disorder (i.e. multiple sclerosis)

• Minimum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Kathryn A Bylow, MD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn Bylow, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10811152 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

00016781

Identifier Type: -

Identifier Source: org_study_id