Soy Isoflavones and Breast Cancer Risk Reduction

NCT00204490 | Completed Phase 2 Results

• 5 other identifiers: 03-260UTMB GCRC #635R01CA095545M01RR0000731UL1RR029876-01
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

soy; isoflavones; phytoestrogens; prevention; mammographic density; bone density

Outcome Measures

Primary Outcomes (2)

• Fibroglandular Tissue in Total Breast (FGBT%)

  Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%.

  baseline, and after year 1 and 2 of supplementation

• Breast Density by Mammography

  Area of FGBT in mammogram. The timepoints were combined and summed.

  baseline, and after year 1 and 2 of supplementation

Secondary Outcomes (1)

• Bone Mineral Density

  one and two years after dietary supplement

Study Arms (2)

1

EXPERIMENTAL

soy isoflavones

Dietary Supplement: isoflavones

2

PLACEBO COMPARATOR

carbohydrates (maltodextrin)

Dietary Supplement: carbohydrate

Interventions

isoflavones DIETARY_SUPPLEMENT

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.

Also known as: Isoflavone pill

1

carbohydrate DIETARY_SUPPLEMENT

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.

Also known as: Sugar pill

2

Eligibility Criteria

• Age: 30 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy premenopausal women
• to 42 years old
• normal mammograms
• regular menstrual cycles

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

General Clinical Reserach Center, The University of Texas Medical Branch

Galveston, Texas, 77555-0264, United States

Location

Related Publications (4)

• Lu LW, Chen NW, Brunder DG, Nayeem F, Nagamani M, Nishino TK, Anderson KE, Khamapirad T. Soy isoflavones decrease fibroglandular breast tissue measured by magnetic resonance imaging in premenopausal women: A 2-year randomized double-blind placebo controlled clinical trial. Clin Nutr ESPEN. 2022 Dec;52:158-168. doi: 10.1016/j.clnesp.2022.10.007. Epub 2022 Oct 26.

  PMID: 36513449 DERIVED

• Lu LW, Chen NW, Nayeem F, Nagamani M, Anderson KE. Soy isoflavones interact with calcium and contribute to blood pressure homeostasis in women: a randomized, double-blind, placebo controlled trial. Eur J Nutr. 2020 Sep;59(6):2369-2381. doi: 10.1007/s00394-019-02085-3. Epub 2019 Sep 18.

  PMID: 31535213 DERIVED

• Lu LW, Chen NW, Nayeem F, Ramanujam VS, Kuo YF, Brunder DG, Nagamani M, Anderson KE. Novel effects of phytoestrogenic soy isoflavones on serum calcium and chloride in premenopausal women: A 2-year double-blind, randomized, placebo-controlled study. Clin Nutr. 2018 Dec;37(6 Pt A):1862-1870. doi: 10.1016/j.clnu.2017.11.002. Epub 2017 Nov 11.

  PMID: 29183775 DERIVED

• 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.

  PMID: 23044556 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Isoflavones; Carbohydrates; Sugars

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Lee Jane W. Lu
• Organization: University of Texas Medical Branch Galveston

llu@utmb.edu

409-772-1730

Study Officials

• Lee-Jane W Lu, Ph.D.

  The University of Teas Medical Branch

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group received soy isoflavones (60 mg daidzein, 60 mg gensitein and 16.6 mg glycitein, all as aglycone equivalent) Another group, carbohydrate filler

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2004
• Primary Completion: December 10, 2012
• Study Completion: May 31, 2023
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Locations

US (1)