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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention Active 30 to 42 NCI, Other 03-260 UTMB GCRC #635, NIH R01-CA95545, NIH NCRR GCRC M01 RR00073, NCT00204490

Trial Description

Summary

Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.

Further Study Information

This is a randomized, double-blind study, with two arms and 100 women in each arm. Premenopausal women will be recruited and randomly allocated to take one of the two different dietary supplements in pills daily for 2 years. The two supplements are soy isoflavones (treatment) and placebo (carbohydrates). Both treatment and placebo pills will contain multi-vitamins and minerals. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary supplement periods and analyzed for biomarkers of breast cancer risk. At baseline and after the intervention period, breast density and bone density will be assessed by radiologic techniques. The efficacy of the dietary intervention will be determined by comparing mean changes of serum markers for breast cancer risk,dense breast tissue, and bone mineral density over the two year dietary intervention period in the two supplement groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soy isoflavone supplement will reduce breast density, which may be explained by individual changes in serum markers of breast cancer risk.

Eligibility Criteria

Inclusion Criteria:

• healthy premenopausal women

• 30 to 42 years old

• normal mammograms

• regular menstrual cycles

Exclusion Criteria:

• abnormal mammograms

• first degree relatives with breast cancer

• pregnant or lactating

• peri- or post-menopause

• breast augmentation, reduction or lifting

• on oral contraceptive medications or exogenous hormones

• medically prescribed diets

• allergic reaction to soy products

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Texas Medical Branch

Lee-Jane W Lu, Ph.D.

Principal Investigator

Lee-Jane W Lu, Ph.D.		Ph: 409 772 4661
		Email: llu@utmb.edu

Karl E Anderson, M.D.		Ph: 409 772 4661
		Email: kanderso@utmb.edu

U.S.A.
Texas
	Galveston
	University of Texas Medical Branch
		Lee-Jane W Lu, Ph.D.	Ph: 409-772-4661
			Email: llu@utmb.edu
		Elizabeth B Ruiz	Ph: 409 772 1950
			Email: ebruiz@utmb.edu
		Lee-Jane W Lu, Ph.D.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00204490
Information obtained from ClinicalTrials.gov on July 16, 2008