Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer

J Clin Oncol. 2013 Nov 10;31(32):4092-8. doi: 10.1200/JCO.2012.48.1432. Epub 2013 Sep 30.


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.

Trial registration: ClinicalTrials.gov NCT00354432.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Aged, 80 and over
  • Androgen Antagonists / adverse effects*
  • Cyclohexanols / therapeutic use*
  • Double-Blind Method
  • Hot Flashes / etiology
  • Hot Flashes / prevention & control*
  • Humans
  • Male
  • Middle Aged
  • Prostatic Neoplasms / drug therapy*
  • Quality of Life
  • Selective Serotonin Reuptake Inhibitors / therapeutic use*
  • Soybean Proteins / therapeutic use*
  • Venlafaxine Hydrochloride


  • Androgen Antagonists
  • Cyclohexanols
  • Serotonin Uptake Inhibitors
  • Soybean Proteins
  • Venlafaxine Hydrochloride

Associated data

  • ClinicalTrials.gov/NCT00354432