Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy
NCT ID: NCT00036686
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2002-12-31
2003-03-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Soy protein isolate
Administration Prior to Mastectomy or Lumpectomy.
Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
Treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure.
Soy protein isolate
Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
Placebo
Administration Prior to Mastectomy or Lumpectomy.
Patients receive oral placebo twice daily and oral multivitamins once daily.
Treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure.
Placebo
Arm II: Patients receive oral placebo twice daily and oral multivitamins once daily.
Interventions
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Soy protein isolate
Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
Placebo
Arm II: Patients receive oral placebo twice daily and oral multivitamins once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Nagi B. Kumar, PhD, RD, FADA
Role: STUDY_CHAIR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Coastal Hematology and Oncology, P.C. - Savannah
Savannah, Georgia, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
The Bronx, New York, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Countries
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Other Identifiers
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NCI-5348
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-P02-0214
Identifier Type: OTHER
Identifier Source: secondary_id
0104
Identifier Type: OTHER
Identifier Source: secondary_id
MCC-13021
Identifier Type: -
Identifier Source: org_study_id