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

Purpose

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

Condition	Intervention	Phase
Prostate Cancer	Dietary Supplement: Flav-ein capsules Drug: Placebo	Phase II

MedlinePlus related topics:

Cancer Prostate Cancer

ChemIDplus related topics:

Proteins, soy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Efficacy Study

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

Further study details as provided by University of Kansas:

Primary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	August 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Subjects receive supplement	Dietary Supplement: Flav-ein capsules Soy/isoflavone supplementation
2: Placebo Comparator Subjects will receive placebo	Drug: Placebo Placebo

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594620

Contacts


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

Locations


United States, Kansas
	University of Kansas Medical Center	Recruiting
	Kansas City, Kansas, United States, 66160
	Contact: Andrea Malone, BLA 913-588-1748 amalone2@kumc.edu
	Principal Investigator: Jeffrey M. Holzbeierlein, MD

Sponsors and Collaborators

University of Kansas

Amgen

Investigators


Principal Investigator:	Jeffrey M. Holzbeierlein, MD	University of Kansas

More Information

Responsible Party:	University of Kansas Medical Center ( Jeffrey M. Holzbeierlein, MD )
Study ID Numbers:	9639
First Received:	January 3, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00594620
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Hot Flashes

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	University of Kansas Amgen
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00594620