Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women
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.
|Breast Cancer Endometrial Cancer||Dietary Supplement: Genistein Dietary Supplement: Placebo||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Phase I Multiple Dose Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women|
- Efficacy of genistein on DNA and apoptosis [ Time Frame: 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.
|Study Start Date:||March 2004|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Dietary Supplement: Genistein
oral Genistein twice daily on days 1-84
Other Name: PTI G-2535
Placebo Comparator: Arm II
Dietary Supplement: Placebo
oral Placebo twice daily on days 1-84
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099008
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Principal Investigator:||Steven H. Zeisel, MD, PhD||UNC Lineberger Comprehensive Cancer Center|