Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

January 3, 2008

Last Updated Date

September 15, 2008

Start Date ^ICMJE

August 2004

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

efficacy of using isoflavones as safer alternative to synthetic estrogens [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00594620 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy

Brief 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

Detailed Description

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Efficacy Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Dietary Supplement: Flav-ein capsules
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Subjects receive supplement
Placebo Comparator: Subjects will receive placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Andrea Malone, BLA

913-588-1748

amalone2@kumc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00594620

Responsible Party

Jeffrey M. Holzbeierlein, MD, University of Kansas Medical Center

Study ID Numbers ^ICMJE

9639

Study Sponsor ^ICMJE

University of Kansas

Collaborators ^ICMJE

Amgen

Investigators ^ICMJE

Principal Investigator:

Jeffrey M. Holzbeierlein, MD

University of Kansas

Information Provided By

University of Kansas

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP