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Home > "N" Clinical Trials Conditions > Nutrition Intervention in Treating Women With Breast Cancer  Nutrition Intervention in Treating Women With Breast Cancer
Nutrition Intervention in Treating Women With Breast Cancer
For Condition: prevention of breast cancer,stage 1 breast cancer,stage 2 breast cancer,stage 3A breast cancer
Status: No longer recruiting
Sponsor(s): American Health Foundation ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 48 Years/78 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanielNixon, Study Chair, American Health Foundation
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Sharp Healthcare - Murrieta
Murrieta, California, 92562
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227-1098
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Bennett Cancer Center
Stamford, Connecticut, 06902
United States
Spohn Hospital South
Corpus Christi, Texas, 78414
United States
American Health Foundation
New York City, New York, 10017
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
United States
Texas Oncology, P.A.
Dallas, Texas, 75246
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Permanente Medical Group (060)
Oakland, California, 94611-5400
United States
Midwestern Regional Medical Center
Zion, Illinois, 60099
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Surgical Associates
Albuquerque, New Mexico, 87102
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20007
United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Shands Cancer Center
Gainesville, Florida, 32610
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
John Wayne Cancer Institute
Santa Monica, California, 90404
United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
United States
Palm Beach Oncology-Hematology at the Good Samaritan Medical Center
West Palm Beach, Florida, 33401
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
United States
Women to Women
Yarmouth, Maine, 04096
United States
Additional Information:
Study ID Numbers: CDR0000063537; AHF-WINS,NCI-H94-0001,MRMC-CTCA-9604,WINS-1
Study Start Date: April 1994
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002564
Other Stage 1 Breast Cancer Studies:
1. Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer
2. Axillary Drainage Following Lymph Node Dissection in Women With Stage I or Stage II Breast Cancer
3. Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
4. Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer
5. Combination Chemotherapy in Treating Women With Breast Cancer
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other Florida Clinical Trials
Other Gainesville Clinical Trials
Nutrition Intervention in Treating Women With Breast Cancer
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