Ignite Creation Date:
2024-05-05 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002564
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
1999-11-01
Brief Title:
Nutrition Intervention in Treating Women With Breast Cancer
Sponsor:
Institute for Cancer Prevention IFCP
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 USDADHHS 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 2500 women will be accrued for this study
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 USDADHHS 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 2500 women will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-H94-0001 | None | None | None |
| AHF-WINS | None | None | None |
| MRMC-CTCA-9604 | None | None | None |
| WINS-1 | None | None | None |