A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study
18 Years
N/A
Female
Breast Cancer
Trial Information
A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Occurrence of Soy Protein Isolate Effect
Outcome Description:
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.
Outcome Time Frame:
1 Year
Safety Issue:
No
Principal Investigator
Nagi B. Kumar, PhD, RD, FADA
Investigator Role:
Study Chair
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Federal Government
Study ID:
MCC-13021
NCT ID:
NCT00036686
Start Date:
December 2002
Completion Date:
March 2003
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- recurrent breast cancer
- stage IV breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| 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 |
