Clinical Trial: Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Isoflavones on Cognition, Quality of Life and Hot Flashes in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy

Brief Summary: This study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are being treated with testosterone suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will result in at least a 50% reduction in hot flashes compared to placebo.

Detailed Summary: This research study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are undergoing (ADT) androgen deprivation therapy. Participants will be given either placebo or Revival. Participants will be asked to take their supplement once/day for 14 weeks.Blood will be drawn to check on liver, kidney, thyroid, cholesterol,and prostate health. Urine will be collected to check on bone markers. Patients will be asked to complete questionnaires to test memory, attention span, and vocabulary.Possible benefits may include increase in memory, decrease in hot flashes, and a general increase in quality of life.
Sponsor: Johns Hopkins University

Current Primary Outcome:

  • cognition using standardized testing procedures [ Time Frame: every 6 weeks from visit 3 ]
  • quality of life (QOL) using standardized testing procedures [ Time Frame: every 6 weeks from visit 3 ]


Original Primary Outcome:

Current Secondary Outcome:

  • hot flashes [ Time Frame: every visit from visit 2 ]
  • sleep [ Time Frame: every 6 weeks from visit 3 ]
  • sexual function [ Time Frame: every 6 weeks from visit 3 ]
  • hormones [ Time Frame: every 6 weeks from visit 3 ]


Original Secondary Outcome:

Information By: Johns Hopkins University

Dates:
Date Received: October 26, 2005
Date Started: June 2005
Date Completion:
Last Updated: January 27, 2009
Last Verified: January 2009