A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 1
- Locations
- 14
- Primary Endpoint
- Occurrence of Soy Protein Isolate Effect
Study Overview
Brief Summary
RATIONALE: Eating a diet rich in soy foods may slow the progression of some types of cancer. Isoflavones are compounds found in soy food that may slow the growth of breast cancer cells and prevent further development of breast cancer.
PURPOSE: Randomized pilot trial to study the effectiveness of isoflavones in preventing further development of breast cancer in women who are planning to undergo mastectomy or lumpectomy.
Detailed Description
OBJECTIVES:
- Determine the effect of soy protein isolate (isoflavones) on modulation of intermediate endpoint biomarkers (such as cell proliferation, apoptosis, and steroid hormones) in women planning to undergo mastectomy or lumpectomy for breast cancer.
- Determine the effect of soy protein isolate on serum isoflavone levels in these patients.
- Correlate changes in serum isoflavones with changes in cell proliferation, apoptosis, and hormonal levels in patients treated with this therapy.
- Correlate the changes in cell proliferation and apoptosis with hormonal markers in patients treated with this therapy.
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to the phase of the menstrual cycle at time of biopsy and time of surgery (follicular phase [i.e., during first 7 days of menstrual cycle] vs luteal phase [i.e., after day 7 of the menstrual cycle]). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
- Arm II:Patients receive oral placebo twice daily and oral multivitamins once daily.
In both arms, treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Occurrence of Soy Protein Isolate Effect
Time Frame: 1 Year
Determine the effect of soy protein isolate (isoflavones) on modulation of intermediate endpoint biomarkers (such as cell proliferation, apoptosis, and steroid hormones) in women planning to undergo mastectomy or lumpectomy for breast cancer.
Secondary Outcomes
- Occurrence of Effect on Serum Isoflavone Levels(1 Year)