Nutrition Intervention in Treating Women With Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002564
First received: November 1, 1999
Last updated: September 16, 2013
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Other: educational intervention
Procedure: therapeutic dietary intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 2500
Study Start Date: April 1994
Study Completion Date: December 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   48 Years to 78 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002564

  Show 37 Study Locations
Sponsors and Collaborators
Institute for Cancer Prevention
Investigators
Study Chair: Daniel W. Nixon, MD Medical University of South Carolina
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002564     History of Changes
Other Study ID Numbers: CDR0000063537, AHF-WINS, MRMC-CTCA-9604, WINS-1, NCI-H94-0001
Study First Received: November 1, 1999
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014