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

NCT ID: NCT00594620

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2010-04-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Subjects receive supplement

Group Type: EXPERIMENTAL

Flav-ein capsules

Intervention Type: DIETARY_SUPPLEMENT

Soy/isoflavone supplementation

2

Subjects will receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Flav-ein capsules

Soy/isoflavone supplementation

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey M. Holzbeierlein, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

9639

Identifier Type: -

Identifier Source: org_study_id