Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
Phase 2
Terminated
- Conditions
- Prostate Cancer
- Interventions
- Dietary Supplement: Flav-ein capsulesDrug: Placebo
- Registration Number
- NCT00594620
- Lead Sponsor
- University of Kansas Medical Center
- Brief Summary
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
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 11
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Flav-ein capsules Subjects receive supplement 2 Placebo Subjects will receive placebo
- Primary Outcome Measures
Name Time Method Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens 16 Weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States