Clinical trial NCT00036686: Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy
Official title: A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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: 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 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

Primary outcomes:
measure: Occurrence of Soy Protein Isolate Effect
timeFrame: 1 Year
Secondary outcomes:
measure: Occurrence of Effect on Serum Isoflavone Levels
timeFrame: 1 Year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: CCOP - Western Regional, Arizona
state: Arizona
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Savannah
country: United States
facility: Coastal Hematology and Oncology, P.C. - Savannah
state: Georgia
city: Springfield
country: United States
facility: St. John's Regional Health Center
state: Missouri
city: Springfield
country: United States
facility: Hulston Cancer Center at Cox Medical Center South
state: Missouri
city: Bronx
country: United States
facility: Comprehensive Cancer Center at Our Lady of Mercy Medical Center
state: New York
city: Fargo
country: United States
facility: CCOP - Merit Care Hospital
state: North Dakota
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Nagi B. Kumar, PhD, RD, FADA
role: STUDY_CHAIR
References: