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Soy Isoflavones and Breast Cancer Risk Reduction

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00204490
First received: September 12, 2005
Last updated: June 5, 2014
Last verified: June 2014

September 12, 2005
June 5, 2014
April 2004
December 2014   (final data collection date for primary outcome measure)
Breast density [ Time Frame: one or two years after dietary supplements ] [ Designated as safety issue: Yes ]
Breast density
Complete list of historical versions of study NCT00204490 on ClinicalTrials.gov Archive Site
bone density [ Time Frame: one or two years after dietary supplement ] [ Designated as safety issue: Yes ]
bone density
Not Provided
Not Provided
 
Soy Isoflavones and Breast Cancer Risk Reduction
Mammographic Density and Soy Isoflavones

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Breast Cancer
  • 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
  • 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
  • Experimental: 1
    soy isoflavones
    Intervention: Dietary Supplement: isoflavones
  • Placebo Comparator: 2
    carbohydrates (maltodextrin)
    Intervention: Dietary Supplement: carbohydrate
Lu LJ, Nishino TK, Johnson RF, Nayeem F, Brunder DG, Ju H, Leonard MH, Grady JJ, Khamapirad T. Comparison of breast tissue measurements using magnetic resonance imaging, digital mammography and a mathematical algorithm. Phys Med Biol. 2012 Nov 7;57(21):6903-27. doi: 10.1088/0031-9155/57/21/6903. Epub 2012 Oct 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
187
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Female
30 Years to 42 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00204490
03-260, UTMB GCRC #635, R01CA095545, M01RR000073, 1UL1RR029876-01
No
The University of Texas, Galveston
The University of Texas, Galveston
  • National Cancer Institute (NCI)
  • National Center for Research Resources (NCRR)
Principal Investigator: Lee-Jane W Lu, Ph.D. The University of Teas Medical Branch
The University of Texas, Galveston
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP