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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00594620
First Posted: January 15, 2008
Last Update Posted: May 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Amgen
Information provided by:
University of Kansas Medical Center
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • efficacy of using isoflavones as safer alternative to synthetic estrogens [ Time Frame: 16 Weeks ]

Enrollment: 11
Study Start Date: August 2004
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subjects receive supplement
Dietary Supplement: Flav-ein capsules
Soy/isoflavone supplementation
Placebo Comparator: 2
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594620


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Amgen
Investigators
Principal Investigator: Jeffrey M. Holzbeierlein, MD University of Kansas Medical Center
  More Information

Responsible Party: Jeffrey M. Holzbeierlein, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00594620     History of Changes
Other Study ID Numbers: 9639
First Submitted: January 3, 2008
First Posted: January 15, 2008
Last Update Posted: May 11, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs