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Home > "I" Clinical Trials Conditions > Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy  Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy
Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy
For Condition: Breast Cancer
Status: No longer recruiting
Sponsor(s): H. Lee Moffitt Cancer Center and Research Institute , National Cancer Institute (NCI)
Synopsis: 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: Randomizedpilot trial to study the effectiveness of isoflavones in preventing further development of breast cancer in women who are planning to undergo mastectomy or lumpectomy.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Undergoing breast biopsy for any stage breast cancer - No excisional biopsy - At least one core biopsy block must contain carcinoma - Definitive surgery (mastectomy or lumpectomy) planned for 2-4 weeks after registration to this study - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Premenopausal Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - No known prior hepatic disease Renal: - No known prior renal disease Other: - Not pregnant or nursing - Fertile patients must use effective non-hormonal contraception - No other prior malignancy except nonmelanoma skin cancer - No known prior thyroid disease - No adherence to vegan diet or other special dietary requirements that would preclude study participation - No allergy to study agent - No obesity (body mass index greater than 32) PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No concurrent birth control pills or other hormonal therapy - No concurrent thyroid hormone replacement medications Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - More than 30 days since prior antibiotics - More than 4 weeks since prior soy products - No routine consumption of greater than 40 mg of soy/day - No other concurrent nutritional supplements, including modular supplements of other isoflavones
Total Enrollment:
Location and Contact Information:
Overall Study Official:
N.B.Kumar, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
Bronx, New York, 10466
United States
Coastal Hematology and Oncology, P.C. - Savannah
Savannah, Georgia, 31406
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
United States
St. John's Regional Health Center
Springfield, Missouri, 65804-2263
United States
Additional Information:
Study ID Numbers: CDR0000069230; MCC-0104,NCI-5348,NCI-P02-0214
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036686
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Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy
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