Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Thera

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Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs



Phase IV


Supportive care


Active


21 and over


NCI, Other


04-08-09-04
NCT00245518


Trial Description


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.

Further Study Information

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.

Eligibility Criteria

Inclusion Criteria:

men > or =21 with prostate CA and hypogonadism for at least 3 months more than 2 episodes of hot flashes/week
Exclusion Criteria:

on growth promoting agents on anti-androgens on appetite stimulating agents on Prednisone and others

Trial Contact Information


Trial Lead Organizations/Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Physicians Laboratories

National Cancer Institute

Shehzad Basaria, M.D. Principal Investigator

Mary A Yep, B.S. Ph: 410-502-3686
Email: maryyep@jhmi.edu

Mary Brunner, B.S. Ph: 410-614-6677
Email: marybelle@jhu.edu

Trial Sites

U.S.A.

Maryland

Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Mary A Yep, B.S. Ph: 410-502-3686
Email: maryyep@jhmi.edu
Mary Brunner, B.S. Ph: 410-614-6677
Email: marybelle@jhu.edu
Shehzad Basaria, M.D. Principal Investigator
Michael A. Carducci Sub-Investigator
Roberto Pili Sub-Investigator
Amy Wisniewski, Ph. D. Sub-Investigator
Adrian S Dobs, M.D. Sub-Investigator
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00245518
Information obtained from ClinicalTrials.gov on May 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.