Nutrition Intervention in Treating Women With Breast Cancer

NCT00002564 | Completed Phase 3

• 5 other identifiers: CDR0000063537AHF-WINSMRMC-CTCA-9604WINS-1NCI-H94-0001
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 37

Brief Summary

RATIONALE: Dietary fat may be involved in the growth of cancer cells. Restricting dietary fat may help fight cancer. PURPOSE: Randomized clinical trial to study the effectiveness of a low fat diet in treating postmenopausal women who have stage I, stage II, or stage IIIA breast cancer that has been completely removed by surgery.

Conditions

Breast Cancer

Keywords

recurrent breast cancer

Interventions

educational intervention OTHER

therapeutic dietary intervention PROCEDURE

Eligibility Criteria

• Age: 48 Years - 78 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically proven, invasive, localized carcinoma of the breast Stage I/II/IIIA disease, i.e.: Tumor confined to breast on clinical examination Overlying skin movable with respect to tumor Tumor movable in relation to underlying muscle and chest wall Bone scan and/or x-ray required to rule out bone metastases in cases of skeletal pain Tumor size requirements: No greater than 5 cm if lymph nodes are positive Greater than 1 cm if lymph nodes are negative Tumor definitively treated by one of the following procedures: Total mastectomy with axillary node dissection Segmental mastectomy with or without axillary node dissection and/or sentinel node biopsy followed by breast irradiation, provided: Surgical margins are histologically free of invasive or noninvasive tumor One additional resection allowed to obtain clear margins Total mastectomy required if clear margins are not obtained at second resection The following conditions exclude: Bilateral malignancy or any mass in the contralateral breast unless proven nonmalignant by biopsy Palpable lymph nodes in the contralateral axilla or probable supraclavicular or infraclavicular nodal involvement unless proven nonmalignant by biopsy 10 or more positive lymph nodes Inflammatory breast cancer Ulceration or erythema Infiltration of the skin or peau d'orange Tethering or dimpling of the skin or nipple inversion should not be considered skin infiltration Satellite breast nodules Parasternal nodules Edema of the arm Hormone receptor status: Any estrogen receptor (ER) or progesterone receptor (PR) status allowed ER assessment required PR assessment recommended Less than 365 days between definitive surgery and randomization PATIENT CHARACTERISTICS: Age: 48 to 78 Sex: Female Menopausal status: Postmenopausal Performance status: Not specified Life expectancy: At least 10 years (excluding breast cancer) Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 60 IU/mL (or within 2 times normal) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active cardiac disease that would preclude doxorubicin in patients assigned to adjuvant chemotherapy with doxorubicin Other: Baseline caloric intake at least 20% fat Accessible for follow-up and by telephone Sufficient memory required to provide food recall data Must speak and read English Medically and nutritionally eligible for either dietary intervention arm No prior or concomitant malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: No concurrent participation in another adjuvant breast cancer trial that has disease-free or overall survival as a study endpoint (e.g., a major cooperative group trial) Biologic therapy: Not specified Chemotherapy: Concurrent adjuvant cyclophosphamide, methotrexate, fluorouracil (CMF), doxorubicin, cyclophosphamide (AC), AC followed by paclitaxel, or fluorouracil/doxorubicin/cyclophosphamide (FAC, CAF) allowed If ER negative, approved chemotherapy regimen and/or tamoxifen required No more than 120 days between definitive surgery and initiation of adjuvant systemic chemotherapy Endocrine therapy: Concurrent adjuvant tamoxifen required if ER positive (if ER negative, tamoxifen and/or an approved chemotherapy regimen required) No more than 180 days between definitive surgery and initiation of tamoxifen (if receiving tamoxifen alone) If receiving adjuvant CMF, AC, or FAC, CAF, or AC, paclitaxel, tamoxifen begins after completion of adjuvant therapy Radiotherapy: Radiotherapy required within 56 days following segmental mastectomy Surgery: Definitive surgery required Prior oophorectomy for reasons other than malignancy allowed

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

Sponsors & Collaborators

• Institute for Cancer Prevention (IFCP): lead

Study Sites (37)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Sharp Healthcare - Murrieta

Murrieta, California, 92562, United States

Location

Permanente Medical Group (060)

Oakland, California, 94611-5400, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Bennett Cancer Center

Stamford, Connecticut, 06902, United States

Location

Lombardi Cancer Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Shands Cancer Center

Gainesville, Florida, 32610, United States

Location

Baptist Regional Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Palm Beach Oncology-Hematology at the Good Samaritan Medical Center

West Palm Beach, Florida, 33401, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Women to Women

Yarmouth, Maine, 04096, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Surgical Associates

Albuquerque, New Mexico, 87102, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

American Health Foundation

New York, New York, 10017, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227-1098, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Spohn Hospital South

Corpus Christi, Texas, 78414, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75246, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• Hoy MK, Winters BL, Chlebowski RT, Papoutsakis C, Shapiro A, Lubin MP, Thomson CA, Grosvenor MB, Copeland T, Falk E, Day K, Blackburn GL. Implementing a low-fat eating plan in the Women's Intervention Nutrition Study. J Am Diet Assoc. 2009 Apr;109(4):688-96. doi: 10.1016/j.jada.2008.12.016.

  PMID: 19328264 RESULT

• Chlebowski RT, Blackburn GL, Thomson CA, Nixon DW, Shapiro A, Hoy MK, Goodman MT, Giuliano AE, Karanja N, McAndrew P, Hudis C, Butler J, Merkel D, Kristal A, Caan B, Michaelson R, Vinciguerra V, Del Prete S, Winkler M, Hall R, Simon M, Winters BL, Elashoff RM. Dietary fat reduction and breast cancer outcome: interim efficacy results from the Women's Intervention Nutrition Study. J Natl Cancer Inst. 2006 Dec 20;98(24):1767-76. doi: 10.1093/jnci/djj494.

  PMID: 17179478 RESULT

• Chlebowski RT, Blackburn GL, Elashoff RE, et al.: Dietary fat reduction in postmenopausal women with primary breast cancer: phase III Women's Intervention Nutrition Study (WINS). [Abstract] J Clin Oncol 23 (Suppl 16): A-10, 3s, 2005.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Daniel W. Nixon, MD

  Medical University of South Carolina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 29, 2004
• Study Start: April 1, 1994
• Study Completion: December 1, 2006
• Last Updated: September 17, 2013

Record last verified: 2010-02

Locations

US (37)