Research: VITOLINS and COLLEAGUES,

Listed in Issue 241

Abstract

VITOLINS and COLLEAGUES,  (1)Mara Z. Vitolins, Leah Griffin, Bart Frizzel, Glenn J. Lesser, Michelle Naughton, and Edward G. Shaw, Wake Forest School of Medicine; Dawn Moose, Novant Health, Winston-Salem; James E. Radford Jr, Hendersonville Hematology /Oncology, Hendersonville, NC; W. Vic Tomlinson, AnMed Health, Anderson, SC; Jacqueline Vuky, Virginia Mason Medical Center, Seattle, WA; and Paul T. Adams, National Surgical Adjuvant Breast and Bowel Project, Genesys Regional Medical Center, Flint, MI conducted a randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer.

Background

Hot flashes occur in approximately 80% of androgen-deprived men. Few intervention studies have been conducted to relieve hot flashes in men.

Methodology

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.

References

Vitolins MZ(1), Griffin L, Tomlinson WV, Vuky J, Adams PT, Moose D, Frizzell B, Lesser GJ, Naughton M, Radford JE Jr, Shaw EG. 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 31(32):4092-8. Nov 10 2013. doi: 10.1200/JCO.2012.48.1432. Epub Sep 30 2013. 

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