Phase III randomized, double-blind, placebo-controlled trial of soy protein and venlafaxine for treatment of hot flashes in men with prostate cancer.

9027 Background: Hot flashes (HFs) occur in approximately 2/3 of androgen-deprived men. There is limited data on treatment from prospective intervention studies. Methods: Eligible androgen-deprived men were randomly assigned to 1 of 4 daily regimens (2x2 factorial design) for 12 weeks: placebo pill and casein protein (P), soy protein and placebo pill (S), venlafaxine (Effexor) and Casein Protein (E), or soy plus venlafaxine (SE). The primary endpoint was hot flash symptom severity score (HFSSS), defined as number x severity of hot flashes. The secondary endpoint was quality of life (QoL), assessed using the FACT-P. Results: 120 men aged 46-91 (median 69 years) participated. Most were Caucasian (78%) and overweight obese (83%). Groups were similar at baseline (BL). Treatment compliance was 88%. Toxicity was minimal. All groups showed a reduction in HFSSS, but there were no significant differences between groups (Table). QoL did not change significantly over time and did not differ between groups. Conclusions: In androgen-deprived men, neither venlafaxine nor soy protein had a significant effect on HFSSS or QoL, in contrast to findings from Quella et al (1999), which reported a 54% decrease in HF score in men taking venlafaxine. Supported by CCOP Research Base Grant 5 U10 CA081851-11. Least squares estimates (SE). Outcome Visit P (N = 30) S (N = 30) E (N = 30) SE (N = 30) P value HFSSS (%BL) Week 4 80.5 (12.9) 75.4 (13.6) 75.0 (14.3) 63.1 (13.6) 0.789 Week 8 58.8 (13.2) 73.9 (14.0) 67.8 (14.7) 66.8 (14.2) 0.873 Week 12 45.2 (13.8) 68.9 (14.4) 64.9 (15.2) 72.2 (15.3) 0.477 FACT-P Baseline 111.5 (4.0) 115.7 (4.0) 119.5 (4.1) 119.6 (4.1) 0.474 Week 12 110.6 (4.2) 120.0 (4.3) 116.2 (4.4) 120.1 (4.4) 0.239