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Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy

This study has been terminated.
(low accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00036686
First received: May 13, 2002
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Breast Cancer
 Dietary Supplement: Soy protein isolate
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Occurrence of Soy Protein Isolate Effect [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Occurrence of Effect on Serum Isoflavone Levels [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Determine the effect of soy protein isolate on serum isoflavone levels in these patients.


Enrollment: 1
Study Start Date: December 2002
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

 Dietary Supplement: Soy protein isolate
Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
Other Name: isoflavones
Placebo Comparator: 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.

 Other: Placebo
Arm II: Patients receive oral placebo twice daily and oral multivitamins once daily.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036686

Locations
United States, Arizona
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Coastal Hematology and Oncology, P.C. - Savannah
Savannah, Georgia, United States, 31406
United States, Missouri
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804-2263
United States, New York
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
Bronx, New York, United States, 10466
United States, North Dakota
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Nagi B. Kumar, PhD, RD, FADA H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00036686     History of Changes
Other Study ID Numbers: MCC-13021, NCI-5348, NCI-P02-0214, 0104
Study First Received: May 13, 2002
Last Updated: September 21, 2012
Health Authority: United States: Federal Government

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013