Effect of Isoflavones on Cognition, Quality of Life and Hot Flashes in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy
21 Years
N/A
Male
Hot Flashes
Trial Information
Effect of Isoflavones on Cognition, Quality of Life and Hot Flashes in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy
This research study will look at the effects of a soy supplement called Revival on memory,
quality of life, and hot flashes in men with prostate cancer who are undergoing (ADT)
androgen deprivation therapy. Participants will be given either placebo or Revival.
Participants will be asked to take their supplement once/day for 14 weeks.Blood will be
drawn to check on liver, kidney, thyroid, cholesterol,and prostate health. Urine will be
collected to check on bone markers. Patients will be asked to complete questionnaires to
test memory, attention span, and vocabulary.Possible benefits may include increase in
memory, decrease in hot flashes, and a general increase in quality of life.
Inclusion Criteria:
- men > or =21 with prostate CA and hypogonadism for at least 3 months
Exclusion Criteria:
- on growth promoting agents
- on appetite stimulating agents
- on Prednisone and others
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
cognition using standardized testing procedures
Outcome Time Frame:
every 6 weeks from visit 3
Safety Issue:
No
Principal Investigator
Shehzad Basaria, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Johns Hopkins University
Authority:
United States: Institutional Review Board
Study ID:
04-08-09-04
NCT ID:
NCT00245518
Start Date:
June 2005
Completion Date:
September 2008
Related Keywords:
- Hot Flashes
- prostate cancer
- soy
- androgen deprivation
- quality of life
- isoflavones
- Prostatic Neoplasms
- Hot Flashes
Name | Location |
|---|---|
| Johns Hopkins University Clinical Trials Unit | Baltimore, Maryland 21205 |
