A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study
- 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
- 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
- Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Occurrence of Soy Protein Isolate Effect
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.
Nagi B. Kumar, PhD, RD, FADA
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|CCOP - Western Regional, Arizona||Phoenix, Arizona 85006-2726|
|Hulston Cancer Center at Cox Medical Center South||Springfield, Missouri 65807|
|St. John's Regional Health Center||Springfield, Missouri 65804|
|Comprehensive Cancer Center at Our Lady of Mercy Medical Center||Bronx, New York 10466|
|Coastal Hematology and Oncology, P.C. - Savannah||Savannah, Georgia 31406|