Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003094
Status:
WITHDRAWN
Last Update Posted:
2014-05-20
First Post:
1999-11-01
Brief Title:
Carotenoid Rich Diet in Treating Cervical Dysplasia
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Carotenoid-Rich Diet Trial to Reverse CIN II
Status:
WITHDRAWN
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was halted prematurely prior to enrollment of first participant
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE A diet rich in carotenoids may be an effective treatment for cervical dysplasia
PURPOSE Randomized phase II trial to study the effectiveness of a carotenoid rich diet in treating patients with cervical dysplasia
PURPOSE Randomized phase II trial to study the effectiveness of a carotenoid rich diet in treating patients with cervical dysplasia
Detailed Description:
OBJECTIVES I Determine whether a carotenoid rich diet will cause a significant increase in the regression of disease in patients with grade I or II cervical intraepithelial dysplasia II Determine whether the regression of disease in this patient population is reflected in the modulation of intermediate biological markers viral genome copy number of human papilloma virus HPV and HPV E6E7 expression
OUTLINE This is a randomized controlled study Patients are randomized to one of two treatment arms Arm I Patients receive dietary counseling and eat 5-10 servings of carotenoid rich fruit and vegetables each day for a year Arm II Patients receive no counseling and maintain their normal diet Carotenoid levels HPV status progression of cervical dysplasia and diet by food frequency checklist and food diary are monitored in both groups
PROJECTED ACCRUAL A total of 240 patients will be accrued for this study within 5 years
OUTLINE This is a randomized controlled study Patients are randomized to one of two treatment arms Arm I Patients receive dietary counseling and eat 5-10 servings of carotenoid rich fruit and vegetables each day for a year Arm II Patients receive no counseling and maintain their normal diet Carotenoid levels HPV status progression of cervical dysplasia and diet by food frequency checklist and food diary are monitored in both groups
PROJECTED ACCRUAL A total of 240 patients 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 |
|---|---|---|---|
| CDR0000065806 | REGISTRY | None | None |
| NCI-P97-0100 | Registry Identifier | PDQ Physician Data Query | None |