Soy Isoflavones and Breast Cancer Risk Reduction

• Sponsor: The University of Texas Medical Branch, Galveston (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00204490
• Collaborator: National Cancer Institute (NCI) (NIH), National Center for Research Resources (NCRR) (NIH)
• Enrollment: 197
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 236.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Dietary Supplement: isoflavones; Dietary Supplement: carbohydrate	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 197 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: One group received soy isoflavones (60 mg daidzein, 60 mg gensitein and 16.6 mg glycitein, all as aglycone equivalent) Another group, carbohydrate fillerOne group received soy isoflavones (60 mg daidzein, 60 mg gensitein and 16.6 mg glycitein, all as aglycone equivalent) Another group, carbohydrate filler
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Research pharmacist dispensed study pills according to a pre-generated randomization list and were blinded to all other aspects of the study protocol. Subjects, research staff, investigators, and statistician all were blinded to treatment assignment.
• Primary Purpose: Treatment
• Official Title: Mammographic Density and Soy Isoflavones
• Actual Study Start Date: Apr 1, 2004
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 soy isoflavones	Dietary Supplement: isoflavones; soy isoflavones: Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other innert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for upto 2 years.; Other Names: Isoflavone pill
Placebo Comparator: 2 carbohydrates (maltodextrin)	Dietary Supplement: carbohydrate; carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other innert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for upto 2 years.; Other Names: Sugar pill

Outcome Measures

Primary Outcome Measures

1. Breast density [one or two years after dietary supplements]

   Amount or percentage of fibroglandular breast tissue in a breast as measured by digital mammography or by magnetic resonance imaging

Secondary Outcome Measures

1. bone density [one or two years after dietary supplement]

   Bone mineral density of whole body, hip and spine as measured by dual x-ray absorptiometry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 42 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Clinical Reserach Center, The University of Texas Medical Branch	Galveston	Texas	United States	77555-0264

Sponsors and Collaborators

• The University of Texas Medical Branch, Galveston
• National Cancer Institute (NCI)
• National Center for Research Resources (NCRR)

Investigators

• Principal Investigator: Lee-Jane W Lu, Ph.D., The University of Teas Medical Branch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT00204490
• Other Study ID Numbers: 03-260; UTMB GCRC #635; R01CA095545; M01RR000073; 1UL1RR029876-01
• First Posted: Sep 20, 2005
• Last Update Posted: Nov 9, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by The University of Texas Medical Branch, Galveston: soy; isoflavones; phytoestrogens; prevention; mammographic density; bone density
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Nov 9, 2021