Effect of β-hydroxy-β-methylbutyrate (HMB) on muscle strength in older men with prostate cancer (Pca) started on androgen deprivation therapy (ADT): Preliminary results of an open-label, randomized trial.
258 Background: ADT causes muscle weakness and wasting within 3 months (mo), causing older men on ADT to experience functional impairments and falls. HMB, a leucine metabolite which decreases muscle protein breakdown, improves strength, fat-free mass and function in older patients when given with arginine (A) and glutamine (G). Use of HMB +AG in older men with PCa starting on ADT to improve muscle loss and function has not been reported. Methods: Men age ≥ 60 with Pca starting on ADT were eligible. 42 men to date have been randomized to receive HMB + AG (Juven) twice daily for 3 mo vs no supplement. Physical performance measures using the Short Physical Performance Battery (SPPB) and hand dynamometer measurements were done at baseline and 3 mo. Both of these validated tests predict morbidity and mortality in older patients. Information on primary outcome, body composition, will be reported in the future according to study plan. Interim results are reported here to describe functional geriatric outcomes. Results: 42 men (mean age 70.2) with Pca (42.4% localized, 27.3% biochemical recurrence, 30.3% metastatic) have enrolled to date. Change in SPPB score favored HMB group: 12.6% of HMB vs 23.1% of controls had decline of ≥ 1point (pt) and 56.3% of HMB vs 15.4% of controls had increase of ≥ 1 pt (p = 0.045). The change in timed chair stand portion of SPPB (measures quadriceps strength) trended in favor of HMB group: -1.5 ± 2.9 seconds (sec) for HMB vs +0.4 ± 2.5 sec for controls, p = 0.073. 41.2% of HMB vs 15.4% of controls experienced an improvement in chair stand score. Change in hand grip strength also favored HMB group: 52.9% of HMB vs 84.6% of controls lost strength and 29.4% of HMB vs 0 controls gained strength, p = 0.047. No significant side effects were reported in HMB group. Conclusions: These are preliminary results of an ongoing trial. HMB is well tolerated in men with PCa on ADT. There is a trend in all measures of muscle function in favor of the HMB group. A much higher than expected % of men on HMB experienced improvement in measures of muscle function despite being on ADT. Further studies are ongoing to clarify the role of HMB in older men on ADT. Clinical trial information: NCT01607879.