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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Flav-ein capsules
Placebo
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Subjects receive supplement

Subjects will receive placebo

Outcomes

Primary Outcome Measures

Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens

Secondary Outcome Measures

Full Information

First Posted
January 3, 2008
Last Updated
February 7, 2022
Sponsor
University of Kansas Medical Center
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00594620
Brief Title
Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
Official Title
A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to poor accrual and without sufficient patients or data to report on any outcomes.
Study Start Date
August 2004 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Subjects receive supplement
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Flav-ein capsules
Intervention Description
Soy/isoflavone supplementation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens
Time Frame
16 Weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M. Holzbeierlein, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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

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