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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00594620
• Other study ID #: 9639
• Status: Terminated
• Phase: Phase 2
• Start date: August 2004
• Est. completion date: April 2010

Study information

• Verified date: January 2022
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hot Flashes
• Prostate Cancer

Intervention

Dietary Supplement:
• Flav-ein capsules
Soy/isoflavone supplementation

Drug:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens		16 Weeks