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Soy Isoflavones and Breast Cancer Risk Reduction

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00204490
First received: September 12, 2005
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Dietary Supplement: isoflavones
Dietary Supplement: carbohydrate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Mammographic Density and Soy Isoflavones

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Breast density [ Time Frame: one or two years after dietary supplements ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • bone density [ Time Frame: one or two years after dietary supplement ] [ Designated as safety issue: Yes ]

Enrollment: 187
Study Start Date: April 2004
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Sugar pill

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.

  Eligibility

Ages Eligible for Study:   30 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204490

Locations
United States, Texas
General Clinical Reserach Center, The University of Texas Medical Branch
Galveston, Texas, United States, 77555-0264
Sponsors and Collaborators
The University of Texas, 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
  More Information

No publications provided by The University of Texas, Galveston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00204490     History of Changes
Other Study ID Numbers: 03-260, UTMB GCRC #635, R01CA095545, M01RR000073, 1UL1RR029876-01
Study First Received: September 12, 2005
Last Updated: May 1, 2012
Health Authority: United States: Federal Government

Keywords provided by The University of Texas, Galveston:
soy
isoflavones
phytoestrogens
 prevention
mammographic density
bone density

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013