Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003365
Status:
TERMINATED
Last Update Posted:
2011-01-27
First Post:
1999-11-01
Brief Title:
Sulindac and Plant Compounds in Preventing Colon Cancer
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
The Effect of Plant Phenolic Compounds on Human Colon Epithelial Cells
Status:
TERMINATED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of sulindac may be an effective way to prevent colon cancer Eating a diet rich in fruits and vegetables appears to reduce the risk of some types of cancer Curcumin rutin and quercetin are compounds found in plants that may prevent the development of colon cancer
PURPOSE Randomized clinical trial to study the effectiveness of sulindac curcumin rutin and quercetin in preventing colon cancer
PURPOSE Randomized clinical trial to study the effectiveness of sulindac curcumin rutin and quercetin in preventing colon cancer
Detailed Description:
OBJECTIVES
Determine the response of the colonic epithelium in normal volunteers at average or above average risk of colon cancer when given short term treatment with plant phenolics such as curcumin rutin and quercetin
Compare the colonic mucosal response to the plant phenolics with their response to sulindac in order to evaluate whether they share common mechanisms for colon cancer chemoprevention
Determine the lowest optimal dose for each of the three plant phenolics that is effective in modulating biomarkers of colon epithelial cell turnover and therefore potentially inhibiting colon cancer development
Assess the response of the colonic epithelium to curcumin in volunteers at average risk of colon cancer development
OUTLINE This is a randomized controlled two part single institution study Patients in Part B are randomized by gender
All patients undergo flexible sigmoidoscopic exam
Part A Patients in cohorts of 5-10 receive one of the following five treatments in addition to the control diet nothing arm I oral sulindac twice a day arm II oral rutin at 1 of 3 doses twice a day arms III IV and V oral quercetin at 1 of 3 doses twice a day arms V VI and VII or at 1 of 3 doses oral curcumin twice a day arms VIII IX and X Patients are first randomized to the highest doses of rutin quercetin and curcumin and then lower doses may be given in order to determine the minimally effective dose Treatment is continued for 6-10 weeks
Part B Patients are randomized to receive the control diet only arm I or the control diet plus oral curcumin twice a day arm II for 6-10 weeks
Patients are followed every 2 weeks
PROJECTED ACCRUAL There will be 130 patients 110 in Part A and 20 in Part B accrued into this study
Determine the response of the colonic epithelium in normal volunteers at average or above average risk of colon cancer when given short term treatment with plant phenolics such as curcumin rutin and quercetin
Compare the colonic mucosal response to the plant phenolics with their response to sulindac in order to evaluate whether they share common mechanisms for colon cancer chemoprevention
Determine the lowest optimal dose for each of the three plant phenolics that is effective in modulating biomarkers of colon epithelial cell turnover and therefore potentially inhibiting colon cancer development
Assess the response of the colonic epithelium to curcumin in volunteers at average risk of colon cancer development
OUTLINE This is a randomized controlled two part single institution study Patients in Part B are randomized by gender
All patients undergo flexible sigmoidoscopic exam
Part A Patients in cohorts of 5-10 receive one of the following five treatments in addition to the control diet nothing arm I oral sulindac twice a day arm II oral rutin at 1 of 3 doses twice a day arms III IV and V oral quercetin at 1 of 3 doses twice a day arms V VI and VII or at 1 of 3 doses oral curcumin twice a day arms VIII IX and X Patients are first randomized to the highest doses of rutin quercetin and curcumin and then lower doses may be given in order to determine the minimally effective dose Treatment is continued for 6-10 weeks
Part B Patients are randomized to receive the control diet only arm I or the control diet plus oral curcumin twice a day arm II for 6-10 weeks
Patients are followed every 2 weeks
PROJECTED ACCRUAL There will be 130 patients 110 in Part A and 20 in Part B accrued into 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-V98-1425 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016056 |
| P30CA016056 | NIH | None | None |
| RUH-SSH-190-0600 | None | None | None |
| RUH-SSH-190-0698 | None | None | None |