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Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy

This study has been completed.
Sponsor:
Collaborators:
Physicians Laboratories
National Cancer Institute (NCI)
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00245518
First received: October 26, 2005
Last updated: January 27, 2009
Last verified: January 2009
History of Changes

October 26, 2005
January 27, 2009
June 2005
September 2008   (final data collection date for primary outcome measure)
  • cognition using standardized testing procedures [ Time Frame: every 6 weeks from visit 3 ] [ Designated as safety issue: No ]
  • quality of life (QOL) using standardized testing procedures [ Time Frame: every 6 weeks from visit 3 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00245518 on ClinicalTrials.gov Archive Site
  • hot flashes [ Time Frame: every visit from visit 2 ] [ Designated as safety issue: No ]
  • sleep [ Time Frame: every 6 weeks from visit 3 ] [ Designated as safety issue: No ]
  • sexual function [ Time Frame: every 6 weeks from visit 3 ] [ Designated as safety issue: No ]
  • hormones [ Time Frame: every 6 weeks from visit 3 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy
Effect of Isoflavones on Cognition, Quality of Life and Hot Flashes in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy

This 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 being treated with testosterone suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will result in at least a 50% reduction in hot flashes compared to placebo.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Hot Flashes
Drug: Revival soy
1 packet of placebo/daily from visit 2 to visit 3, 1 packet of placebo/supplement daily from visit 3 to visit 5.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Male
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00245518
04-08-09-04
Yes
Shehzad Basaria MD, Johns Hopkins University School of Medicine
Johns Hopkins University
  • Physicians Laboratories
  • National Cancer Institute (NCI)
Principal Investigator: Shehzad Basaria, M.D. Johns Hopkins University
Johns Hopkins University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP