A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
efficacy of using isoflavones as safer alternative to synthetic estrogens
Outcome Time Frame:
16 Weeks
Safety Issue:
Yes
Principal Investigator
Jeffrey M. Holzbeierlein, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Kansas
Authority:
United States: Institutional Review Board
Study ID:
9639
NCT ID:
NCT00594620
Start Date:
August 2004
Completion Date:
April 2010
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
- Hot Flashes
Name | Location |
|---|---|
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
