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

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Dietary supplement: Soy protein isolate; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006-2726
      • CCOP - Western Regional, Arizona
  • Florida
    • Tampa, Florida, United States, 33612-9497
      • H. Lee Moffitt Cancer Center and Research Institute
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Coastal Hematology and Oncology, P.C. - Savannah
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Hulston Cancer Center at Cox Medical Center South
    • Springfield, Missouri, United States, 65804-2263
      • St. John's Regional Health Center
  • New York
    • Bronx, New York, United States, 10466
      • Comprehensive Cancer Center at Our Lady of Mercy Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • CCOP - Merit Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Soy Protein Isolate Effect	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.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Effect on Serum Isoflavone Levels	Determine the effect of soy protein isolate on serum isoflavone levels in these patients.	1 Year

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Nagi B. Kumar, PhD, RD, FADA, H. Lee Moffitt Cancer Center and Research Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): March 1, 2003
• Study Completion (Actual): March 1, 2003

Study Registration Dates

• First Submitted: May 13, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): September 24, 2012
• Last Update Submitted That Met QC Criteria: September 21, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer; stage II breast cancer; stage IIIC breast cancer; stage I breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MCC-13021; NCI-5348 (Other Identifier: NCI); NCI-P02-0214 (Other Identifier: NCI); 0104 (CCOP)