Hot Flash Treatments That Help Women Fail to Benefit Androgen-Deprived Men

Mara Vitolins, DrPH, MPH, RD

Men who experience hot flashes because they are undergoing androgen-deprivation therapy for prostate cancer are not significantly helped by two treatments that alleviate that symptom in menopausal women, the results of a study show.

“Changing hormone levels cause hot flashes in both women and men, so we hoped that using soy supplements and/or an antidepressant would help reduce the side effect in men as it does in a similar way in many women,” said Mara Vitolins, DrPH, MPH, RD, professor of Public Health Sciences at Wake Forest Baptist Medical Center and lead author of the study, which was published in the September 30 online issue of the Journal of Clinical Oncology.

Eighty percent of androgen-deprived men experience vasomotor symptoms (ie, hot flashes and night sweats), yet there have been few intervention studies aimed at relieving the symptoms in men.

The phase III, double-blind, multicenter study followed 120 androgen-deprived men (median age, 69 years), most of whom were Caucasian and obese.

The men were assigned to one of four daily regimens for 12 weeks: milk protein powder and placebo; milk protein powder and the antidepressant venlafaxine; soy protein powder and placebo; or soy protein powder and venlafaxine. The researchers reported that there were no significant patient differences among the four arms.

Phase III Study of Hot Flash Treatment in Androgen-Deprived Men^a,b

% Decrease in HFSSS

Venlafaxine + soy

28

Venlafaxine + milk protein powder

35

Soy + placebo

31

Placebo + milk protein powder

55

^{aStudy involved 120 androgen-deprived men. bData were accrued after 12 weeks of treatment. HFSSS indicates hot flash symptom severity score, defined as thenumber of hot flashes times severity.}

The primary endpoint was hot flash symptom severity score (HFSSS), defined as the number of hot flashes times severity ratings (1 = mild; 2 = moderate; 3 = severe). This score was recorded daily and a weekly mean score was calculated and used in the analyses.

The secondary endpoint was quality of life (QOL), assessed by using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, plus a prostatespecific subscale (FACT-P). The prostate subscale features 12 questions specific to prostate cancer, and scores range from 0 to 48. The FACT-P score is the sum of the FACT-G score and the prostate-specific subscale score. Higher scores indicate better QOL.

The investigators found no significant effect on HFSSS because of the use of venlafaxine or soy protein, either as single therapy or in combination. Soy protein alone improved measures of QOL in the men. The toxicity of the agents used in the study was minimal, the authors reported.

At week 12, the researchers reported a 28% decrease in HFSSS in the venlafaxine plus soy arm, a 35% decrease in the venlafaxine arm, a 31% decrease in the soy arm, and a 55% decrease in the placebo arm.

“Utilizing interventions that appear effective in decreasing hot flashes in women to treat men who have hot flashes has proven to be relatively ineffective,” Vitolins said.

These findings highlight the need for continuing efforts to identify treatments for hot flashes that are specifically developed for men, she said.

Vitolins MZ, Griffin L, Tomlinson WV, et al. Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer [published online ahead of print September 30, 2013]. J Clin Oncol. doi: 10.1200/JCO.2012.48.1432.