NCT00099008

Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women

Phase I Multiple Dose Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer
• Endometrial Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Genistein	oral Genistein twice daily on days 1-84
DIETARY_SUPPLEMENT	Placebo	oral Placebo twice daily on days 1-84

Timeline

• Start date: 2004-03-01
• Primary completion: 2005-07-01
• Completion: 2006-07-01
• First posted: 2004-12-09
• Last updated: 2013-05-21

Locations

1 site across 1 country: United States