Clinical trial · Interventional
Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation
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
NCT01607879CI-TRIAL-00069862completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of care ADT | Other | — | UNRESOLVED |
| Standard of care ADT + (HMB + arginine + glutamine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Standard of care ADT + (HMB + AG)
- description
- Standard of care androgen deprivation therapy plus the nutritional supplement HMB + arginine + glutamine (AG)
- interventionNames
- Drug: Standard of care ADT + (HMB + arginine + glutamine)
- type
- ACTIVE_COMPARATOR
- label
- Standard of care ADT
- description
- Standard of care androgen deprivation therapy
- interventionNames
- Other: Standard of care ADT
Primary outcomes (1)
- measure
- Change From Baseline in Body Composition (Lean Body Mass)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 60 Years
Show eligibility criteria text
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)
References
Publications (1)
- BACKGROUNDGuralnik 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