Finding studies
Finding studies
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Lead
H. Lee Moffitt Cancer Center and Research Institute
With
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. PROJECTED ACCRUAL: A total of 106 patients (53 per treatment arm) will be accrued for this study within 18 months.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted