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

This study is currently recruiting participants.

Verified by University of Kansas, September 2008

First Received: January 3, 2008 Last Updated: September 15, 2008 History of Changes

Sponsor:	University of Kansas
Collaborator:	Amgen
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00594620

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Prostate Cancer

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on November 09, 2009