Study Stopped
Terminated due to poor accrual and without sufficient patients or data to report on any outcomes.
Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
1 other identifier
interventional
11
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 prostate-cancer
Started Aug 2004
Typical duration for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 3, 2008
CompletedFirst Posted
Study publicly available on registry
January 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
February 8, 2022
CompletedFebruary 14, 2022
January 1, 2022
5.7 years
January 3, 2008
June 26, 2020
February 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens
16 Weeks
Study Arms (2)
1
EXPERIMENTALSubjects receive supplement
2
PLACEBO COMPARATORSubjects will receive placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kansas Medical Centerlead
- Amgencollaborator
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination due to low accrual. Insufficient number of participants for accurate analysis. No data collected.
Results Point of Contact
- Title
- Jeffrey Holzbeierlein, MD, FACS
- Organization
- The University of Kansas
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey M. Holzbeierlein, MD
University of Kansas Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2008
First Posted
January 15, 2008
Study Start
August 1, 2004
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 14, 2022
Results First Posted
February 8, 2022
Record last verified: 2022-01