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

NCT ID: NCT00245518

Last Updated: 2017-10-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hot Flashes

Keywords

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prostate cancer soy androgen deprivation quality of life isoflavones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Isoflavone

Isoflavone

Group Type EXPERIMENTAL

Isoflavone

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Interventions

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Isoflavone

Intervention Type DRUG

Placebos

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Physicians Laboratories

UNKNOWN

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shehzad Basaria, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University Clinical Trials Unit

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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04-08-09-04

Identifier Type: -

Identifier Source: org_study_id