AzTrials
AzTrials

Breast CancerPhase 3NCT00002564

Nutrition Intervention in Treating Women With Breast Cancer

A Phase 3 study testing educational intervention and therapeutic dietary intervention in people with Breast Cancer, run by Institute for Cancer Prevention (IFCP) at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 48 to 78 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
educational intervention and therapeutic dietary intervention
Type of treatment
Surgery or procedure
How many people
2,500 participants
Where
37 sitesUnited States
Study dates
Apr 1994to Dec 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 48 to 78 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites
  • Surgical Associates

    Albuquerque, New Mexico, 87102

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210

  • Spohn Hospital South

    Corpus Christi, Texas, 78414

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Evanston Northwestern Health Care

    Evanston, Illinois, 60201

  • Shands Cancer Center

    Gainesville, Florida, 32610

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Baptist Regional Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • St. Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Sharp Healthcare - Murrieta

    Murrieta, California, 92562

  • American Health Foundation

    New York, New York, 10017

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Permanente Medical Group (060)

    Oakland, California, 94611-5400

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Kaiser Permanente Center for Health Research

    Portland, Oregon, 97227-1098

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • John Wayne Cancer Institute

    Santa Monica, California, 90404

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Bennett Cancer Center

    Stamford, Connecticut, 06902

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Lombardi Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

  • Palm Beach Oncology-Hematology at the Good Samaritan Medical Center

    West Palm Beach, Florida, 33401

  • Women to Women

    Yarmouth, Maine, 04096

  • Midwestern Regional Medical Center

    Zion, Illinois, 60099

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
educational intervention, therapeutic dietary intervention
Keywords
recurrent breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • educational interventionOther

  • therapeutic dietary interventionProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2004 (estimated)
  2. Study startApr 1994
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
2,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002564
Sponsor's protocol ID
CDR0000063537
Other IDs
AHF-WINS, MRMC-CTCA-9604, WINS-1, NCI-H94-0001
Status last verified
Feb 2010
First submitted
1 Nov 1999
Last updated
17 Sep 2013
Results posted
No

Publications

  • 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.

    PubMed 19328264
  • 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.

    PubMed 17179478
  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing educational intervention and therapeutic dietary intervention in people with Breast Cancer, run by Institute for Cancer Prevention (IFCP) at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002564, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in