Randomized Trial to Assess the Impact of Venlafaxine and Soy Protein on Hot Flashes and Quality of Life in Men With Prostate Cancer
Mené auprès de 120 participants âgés de 46 à 91 ans, cet essai randomisé analyse l'efficacité de la venlafaxine et de protéines de soja sous forme de poudre pour atténuer la sévérité des bouffées de chaleur et améliorer la qualité de vie des patients atteints d'un cancer de la prostate
Purpose : Hot flashes occur in approximately 80% of androgen-deprived men. Few intervention studies have been conducted to relieve hot flashes in men. Patients And methods : Eligible androgen-deprived men were randomly assigned to one of four daily regimens (2 × 2 factorial design) for 12 weeks: milk protein powder and placebo pill, venlafaxine and milk protein powder, soy protein powder and placebo pill, or venlafaxine and soy protein powder. The primary end point was hot flash symptom severity score (HFSSS), defined as number of hot flashes times severity. The secondary end point was quality of life (QoL), assessed by using the Functional Assessment of Cancer Therapy-Prostate. Results In all, 120 men age 46 to 91 years participated. Most were white (78%) and overweight or obese (83%). Toxicity was minimal. Neither venlafaxine nor soy protein alone or in combination had a significant effect on HFSSS. Soy protein, but not venlafaxine, improved measures of QoL. Conclusion In androgen-deprived men, neither venlafaxine nor soy proved effective in reducing hot flashes. Interventions that appear effective for decreasing hot flashes in women may not always turn out to be effective in men.