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Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation 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 II

Supportive care

Active

18 and over

Other

9639
NCT00594620

Trial Description

Summary

To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control of advanced prostate cancer

Further Study Information

Literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. Soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but there has not been a similar study performed on their effect in men on androgen deprivation therapy for prostate cancer.

Eligibility Criteria

Inclusion Criteria:

Histologically proven adenocarcinoma of prostate with treatment of prostate cancer (radical prostatectomy, radiation therapy, etc.)

had biochemical/clinical relapse and started on antiandrogens

have documented history of hot flashes

Exclusion Criteria:

History of MI, DVT, CVA

peanut allergy

untreated hypothyroidism

must be off other medical treatment for hot flashes for 2 weeks before enrollment in this study

Trial Contact Information

Trial Lead Organizations/Sponsors

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Amgen, Incorporated

Jeffrey M. Holzbeierlein, MD

Principal Investigator

Andrea Malone, BLA		Ph: 913-588-1748
		Email: amalone2@kumc.edu

Trial Sites

U.S.A.

Kansas

Kansas City

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Andrea Malone, BLA Ph: 913-588-1748

Email: amalone2@kumc.edu

Jeffrey Holzbeierlein Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00594620
Information obtained from ClinicalTrials.gov on September 17, 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.