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
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00245518
First received: October 26, 2005
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Hot Flashes
Drug: Revival soy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Isoflavones on Cognition, Quality of Life and Hot Flashes in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: June 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245518

Locations
United States, Maryland
Johns Hopkins University Clinical Trials Unit
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Physicians Laboratories
Investigators
Principal Investigator: Shehzad Basaria, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Shehzad Basaria MD, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00245518     History of Changes
Other Study ID Numbers: 04-08-09-04
Study First Received: October 26, 2005
Last Updated: January 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
prostate cancer
soy
androgen deprivation
quality of life
isoflavones

Additional relevant MeSH terms:
Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014