Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003787
Status:
COMPLETED
Last Update Posted:
2019-06-10
First Post:
1999-11-01
Brief Title:
Womens Healthy Eating and Living Study
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Dietary Intervention in Women Who Have Been Treated For Stage I Stage II or Stage III Breast Cancer Womens Healthy Eating and Living WHEL Study
Status:
COMPLETED
Status Verified Date:
2019-06
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 fats fruits vegetables and fiber may affect the risk of breast cancer recurrence
PURPOSE Randomized clinical trial to determine the effectiveness of a diet rich in vegetables fruit and fiber and low in fat in women who have been treated for stage I stage II or stage III breast cancer
PURPOSE Randomized clinical trial to determine the effectiveness of a diet rich in vegetables fruit and fiber and low in fat in women who have been treated for stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES I Determine whether a diet rich in vegetables fruit and fiber and low in fat is associated with a longer breast cancer event-free interval in breast cancer survivors II Motivate an intervention group of breast cancer survivors to adopt and maintain a dietary pattern that is rich in vegetables fruit and fiber and low in fat III Demonstrate that the intervention can produce significant changes in circulating carotenoid and estrogen biomarkers compared to a healthy control diet IV Test whether the probability of a secondary cancer event is associated with change in self-reported dietary intake circulating carotenoid concentrations and circulating estrogen concentrations
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 55 vs 55 and over at time of diagnosis stage of tumor stage I and at least 1 cm vs stage IIIIIA and clinical site Patients are randomized to one of two healthy dietary regimens Arm I Patients are taught to follow a dietary pattern that will produce significant changes in circulating carotenoid and estrogen biomarkers Arm II Patients are assigned to follow dietary guidelines established by the National Cancer Institute and the USDA All patients participate in 24 hour dietary recalls cooking classes as well as complete several questionnaires at baseline and then at 12 24 or 36 48 and 72 months a randomly selected 50 sample participate in recall at 6 months Patients are followed by telephone every 6 months for an average of 6 years
PROJECTED ACCRUAL A total of 3000 women will be accrued for this study within 5 years
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 55 vs 55 and over at time of diagnosis stage of tumor stage I and at least 1 cm vs stage IIIIIA and clinical site Patients are randomized to one of two healthy dietary regimens Arm I Patients are taught to follow a dietary pattern that will produce significant changes in circulating carotenoid and estrogen biomarkers Arm II Patients are assigned to follow dietary guidelines established by the National Cancer Institute and the USDA All patients participate in 24 hour dietary recalls cooking classes as well as complete several questionnaires at baseline and then at 12 24 or 36 48 and 72 months a randomly selected 50 sample participate in recall at 6 months Patients are followed by telephone every 6 months for an average of 6 years
PROJECTED ACCRUAL A total of 3000 women will be accrued for this study within 5 years
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-G99-1508 | Registry Identifier | PDQ Physician Data Query | None |
| UCSD-WHEL | None | None | None |
| CDR0000066920 | REGISTRY | None | None |