Soy Protein/Effexor Hormone Therapy for Prostate Cancer

Summary

RATIONALE: Soy protein/isoflavones and venlafaxine may help relieve hot flashes in patients receiving hormone therapy for prostate cancer. It is not yet known whether soy protein/isoflavones are more effective than venlafaxine when given together or with a placebo in treating hot flashes. PURPOSE: This randomized phase III trial is studying soy protein/isoflavones and venlafaxine to compare how well they work when given together or with a placebo in treating hot flashes in patients receiving hormone therapy for prostate cancer.

Timeline

Start

2007-02-01

Primary completion

2010-08-01

Completion

2010-08-01

Outcome

Missed primary endpoint

Stopped: “Stopped by the DSMB for lack of effect per interim stopping rule.”

registry analysis (unspecified test); Arm I - Placebo vs Arm II - Soy vs Arm III - Venlafaxine vs Arm IV - Soy + Venlafaxine; p = .3455; NCT00354432 ↗

paper Neither venlafaxine nor soy protein alone or in combination had a significant effect on HFSSS. PMID 24081940 ↗

Publications

• Vitolins MZ, 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. 2013 Nov 10;31(32):4092-8. doi: 10.1200/JCO.2012.48.1432. Epub 2013 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venlafaxine	Small molecule	75 mg	Oral

Indications