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A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

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 InstituteTampa, Florida  33612
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Comprehensive Cancer Center at Our Lady of Mercy Medical CenterBronx, New York  10466
Coastal Hematology and Oncology, P.C. - SavannahSavannah, Georgia  31406