Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women

Phase 1

Completed

• Conditions: Breast Cancer; Endometrial Cancer
• Interventions: Dietary Supplement: Genistein; Dietary Supplement: Placebo

• Registration Number: NCT00099008
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of genistein may be effective in preventing breast or endometrial cancer.

PURPOSE: This randomized phase I trial is studying the effectiveness of genistein in preventing breast or endometrial cancer in healthy postmenopausal women.

Detailed Description

OBJECTIVES:

* Compare the effects of genistein vs placebo on DNA damage and apoptosis by conducting COMET, TUNEL, Caspase-3, and AP site assays in healthy postmenopausal women.

* Compare the effects of these drugs on gene expression in an estrogen-sensitive tissue by oligoarray profiling in these participants.

* Determine the effect of genistein on estrogenic effects by self-reported side effects, measurement of sex hormone-binding globulin, follicle-stimulating hormone, luteinizing hormone, and estrogen levels, and expression of known estrogen-sensitive genes in these participants.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are stratified according to their study ID numbers. Participants are randomized to 1 of 2 treatment arms.

* Arm I: Participants receive oral genistein twice daily on days 1-84.

* Arm II: Participants receive oral placebo twice daily on days 1-84. In both arms, treatment continues in the absence of dysplasia, malignancy, unacceptable toxicity, or gross noncompliance.

Participants are followed at days 7, 14, 28, 56, and 84 during study treatment and at day 28 after completion of study treatment.

PROJECTED ACCRUAL: A total of 30 participants (20 for arm I and 10 for arm II) will be accrued for this study.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2004-12-08
• Study First Submitted QC: 2004-12-08
• Study First Posted: 2004-12-09
• Primary Completion: 2005-07
• Study Completion: 2006-07
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	Genistein	Genistein
Arm II	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Efficacy of genistein on DNA and apoptosis	112 days	Compare the effects of genistein vs placebo on DNA damage and apoptosis by conducting COMET, TUNEL, Caspase-3, and AP site assays in healthy postmenopausal women.

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States