Phase 2
N=48
Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01607879 ↗Enrolled (actual)
48
Serious AEs
6.3%
Results posted
Sep 2023
Primary outcome: Primary: Change From Baseline in Body Composition (Lean Body Mass) — 54.93; 57.58; -1.27; -0.60 Kilogram — p=0.1497
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Standard of care ADT + (HMB + arginine + glutamine) (Drug); Standard of care ADT (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Male
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Body Composition (Lean Body Mass) |
54.93; 57.58; -1.27; -0.60 | 0.1497 |
| SECONDARY Change From Baseline of Dorsiflexor Muscle Size in mm^2. |
1378; 1348; -36; 30 | 0.17 |
| SECONDARY Change From Baseline in Strength of the Dorsiflexor Muscle in Kilograms. |
17.2; 18.0; -1.0; 1.0 | 0.75 |
| SECONDARY Physical Performance Measured Using the Short Physical Performance Battery (SPPB) |
10.6; 10.7; 11.1; 11.0 | 0.925 |
| SECONDARY Change From Baseline in the Number of Fall Events |
1; 0; -1; 0 | 1.0 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01607879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.