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

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00594620
First received: January 3, 2008
Last updated: May 10, 2011
Last verified: May 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:

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 ]

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

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

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
  More Information

No publications provided

Responsible Party: Jeffrey M. Holzbeierlein, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00594620     History of Changes
Other Study ID Numbers: 9639
Study First Received: January 3, 2008
Last Updated: May 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Signs and Symptoms
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013