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

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

Mara Z Vitolins  1 , Leah Griffin, W Vic Tomlinson, Jacqueline Vuky, Paul T Adams, Dawn Moose, Bart Frizzell, Glenn J Lesser, Michelle Naughton, James E Radford Jr, Edward G Shaw
Affiliations
Clinical Trial

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

Mara Z Vitolins et al. J Clin Oncol. .

Abstract

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.

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Conflict of interest statement

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
CONSORT diagram. Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer.
Fig 2.
Fig 2.
Hot Flash Symptom Severity Score over time in all four treatment groups.
Fig 3.
Fig 3.
Hot Flash Symptom Severity Score over time in participants receiving venlafaxine and participants not receiving venlafaxine.
Fig 4.
Fig 4.
Hot Flash Symptom Severity Score over time in participants receiving soy and participants not receiving soy.
See this image and copyright information in PMC

References

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