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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soy protein isolate
Placebo
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Western Regional, Arizona
  • H. Lee Moffitt Cancer Center and Research Institute
  • Coastal Hematology and Oncology, P.C. - Savannah
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • Comprehensive Cancer Center at Our Lady of Mercy Medical Center
  • CCOP - Merit Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Soy protein isolate

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Occurrence of Effect on Serum Isoflavone Levels
Determine the effect of soy protein isolate on serum isoflavone levels in these patients.

Full Information

First Posted
May 13, 2002
Last Updated
September 21, 2012
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00036686
Brief Title
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

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
December 2002 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soy protein isolate
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy protein isolate
Other Intervention Name(s)
isoflavones
Intervention Description
Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Arm II: Patients receive oral placebo twice daily and oral multivitamins once daily.
Primary Outcome Measure Information:
Title
Occurrence of Soy Protein Isolate Effect
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.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Occurrence of Effect on Serum Isoflavone Levels
Description
Determine the effect of soy protein isolate on serum isoflavone levels in these patients.
Time Frame
1 Year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagi B. Kumar, PhD, RD, FADA
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Coastal Hematology and Oncology, P.C. - Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804-2263
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States

12. IPD Sharing Statement

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

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