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

NCT00036686 | Terminated

• 4 other identifiers: MCC-13021NCI-5348NCI-P02-02140104
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Occurrence of Effect on Serum Isoflavone Levels

  1 Year

Study Arms (2)

Soy protein isolate

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Soy protein isolate DIETARY_SUPPLEMENT

Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.

Also known as: isoflavones

Soy protein isolate

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Coastal Hematology and Oncology, P.C. - Savannah

Savannah, Georgia, 31406, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804-2263, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Comprehensive Cancer Center at Our Lady of Mercy Medical Center

The Bronx, New York, 10466, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Soybean Proteins; Isoflavones

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nagi B. Kumar, PhD, RD, FADA

  H. Lee Moffitt Cancer Center and Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2002
• First Posted: January 27, 2003
• Study Start: December 1, 2002
• Primary Completion: March 1, 2003
• Study Completion: March 1, 2003
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

US (7)