Nutrition Intervention in Treating Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

A CLINICAL TRIAL TO DETERMINE THE EFFICACY OF A DIETARY FAT REDUCTION PROGRAM PROVIDED IN ADDITION TO SYSTEMIC ADJUVANT THERAPY IN THE MANAGEMENT OF PATIENTS WITH PRIMARY INVASIVE BREAST CANCER

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002564
• Other study ID #: CDR0000063537
• Secondary ID: AHF-WINSMRMC-CTC
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: September 16, 2013
• Start date: April 1994
• Est. completion date: December 2006

Study information

• Verified date: February 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES: I. Determine whether dietary fat reduction will effectively prolong disease-free and overall survival in women surgically treated for early stage breast cancer who are receiving adjuvant therapy with or without either tamoxifen, cyclophosphamide, methotrexate, fluorouracil (CMF), doxorubicin, cyclophosphamide (AC), fluorouracil, doxorubicin, cyclophosphamide (FAC, CAF), or AC followed by paclitaxel. II. Evaluate whether differences in the lipid profile are associated with dietary group assignment and dietary fat.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, nodal status, ER status, and type of adjuvant chemotherapy. The first group receives intensive dietary intervention for reduction of total fat intake to 15% of calories, with repeated individual and group counseling sessions. The second group receives USDA/DHHS dietary guidelines and minimal intervention. All patients who are estrogen receptor positive receive concurrent therapy with tamoxifen; cyclophosphamide, methotrexate, fluorouracil (CMF) followed by tamoxifen; doxorubicin, cyclophosphamide (AC) followed by tamoxifen; fluorouracil, doxorubicin, cyclophosphamide (FAC, CAF) followed by tamoxifen; or AC, paclitaxel followed by tamoxifen. Patients are followed annually throughout the study.

PROJECTED ACCRUAL: Approximately 2,500 women will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 48 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• educational intervention

Procedure:
• therapeutic dietary intervention

Locations

Country	Name	City	State
United States	Surgical Associates	Albuquerque	New Mexico
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Spohn Hospital South	Corpus Christi	Texas
United States	Texas Oncology, P.A.	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Evanston Northwestern Health Care	Evanston	Illinois
United States	Shands Cancer Center	Gainesville	Florida
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Baptist Regional Cancer Institute - Jacksonville	Jacksonville	Florida
United States	St. Barnabas Medical Center	Livingston	New Jersey
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Sylvester Cancer Center, University of Miami	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	Sharp Healthcare - Murrieta	Murrieta	California
United States	American Health Foundation	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Permanente Medical Group (060)	Oakland	California
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Kaiser Permanente Center for Health Research	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	John Wayne Cancer Institute	Santa Monica	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Bennett Cancer Center	Stamford	Connecticut
United States	Arizona Cancer Center	Tucson	Arizona
United States	Lombardi Cancer Center, Georgetown University	Washington	District of Columbia
United States	Palm Beach Oncology-Hematology at the Good Samaritan Medical Center	West Palm Beach	Florida
United States	Women to Women	Yarmouth	Maine
United States	Midwestern Regional Medical Center	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Cancer Prevention (IFCP)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

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, Elashof — View Citation

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- — View Citation