Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365209
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2006-08-16
Brief Title:
Phase II A Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions Aberrant Crypt Foci
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase IIA Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions Aberrant Crypt Foci
Status:
COMPLETED
Status Verified Date:
2014-03
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:
Chemoprevention is the use of certain substances to keep cancer from forming growing or coming back Curcumin is a compound found in plants that may prevent colon cancer from forming This phase II trial is studying how well curcumin works in preventing colon cancer in smokers with aberrant crypt foci
Detailed Description:
PRIMARY OBJECTIVES
I To determine mean percentage change from baseline in prostaglandin E2 PGE2 within ACF pre and post 30 days of curcumin administration at a specified dose
SECONDARY OBJECTIVS
I To determine mean percentage change from baseline in 5-hydroxy-eicosatetraenoic acid 5-HETE within ACF pre and post 30 days of curcumin administration at a specified dose
II To determine mean percentage change from baseline in PGE2 and 5-HETE within comparison normal mucosa pre and post 30 days of curcumin administration at a specified dose
III To quantify corresponding enzyme changes in the cyclooxygenases COX-1 COX-2 and lipoxygenase 5-LOX protein abundance Semi-quantitative changes in these proteins will be measured by western blotting and correlated with changes in prostaglandins and leukotrienes respectively
IV Document changes in total ACF number V Determine proliferation by Ki-67 IHC in rectal mucosa pre and post therapy and correlate with changes in ACF number and size
VI Determine curcumin concentration in rectal mucosa after 30 days therapy and correlate with PGE2 and 5-HETE changes described above
VII Measure glutathione peroxidase GPx activity within the colon pre and post therapy as an indirect marker of reduced oxidative stress within the colonic epithelium
VIII Ensure safety of all participants during course of study investigation IX Determine the curcumin concentration in plasma before and after treatment
OUTLINE This is a multicenter nonrandomized uncontrolled study
Patients receive 1 of 2 doses of oral curcumin once daily Treatment continues for 30 days in the absence of unacceptable toxicity or disease progression
Blood and tissue biopsies are obtained by sigmoidoscopy or colonoscopy at baseline and at day 30 for correlative biomarker studies The change in prostaglandin E_2 PGE_2 is assessed by enzyme immunoassay 5-hydroxy-eicosatetraenoic acid 5-HETE by high-performance liquid chromatography cyclooxygenases COX-1 and COX-2 and 5-lipoxygenase 5-LOX by western blotting Ki-67 by immunohistochemistry and glutathione peroxidase GPx by spectrophotometric assay
After completion of study therapy patients are followed at 1 week
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study
I To determine mean percentage change from baseline in prostaglandin E2 PGE2 within ACF pre and post 30 days of curcumin administration at a specified dose
SECONDARY OBJECTIVS
I To determine mean percentage change from baseline in 5-hydroxy-eicosatetraenoic acid 5-HETE within ACF pre and post 30 days of curcumin administration at a specified dose
II To determine mean percentage change from baseline in PGE2 and 5-HETE within comparison normal mucosa pre and post 30 days of curcumin administration at a specified dose
III To quantify corresponding enzyme changes in the cyclooxygenases COX-1 COX-2 and lipoxygenase 5-LOX protein abundance Semi-quantitative changes in these proteins will be measured by western blotting and correlated with changes in prostaglandins and leukotrienes respectively
IV Document changes in total ACF number V Determine proliferation by Ki-67 IHC in rectal mucosa pre and post therapy and correlate with changes in ACF number and size
VI Determine curcumin concentration in rectal mucosa after 30 days therapy and correlate with PGE2 and 5-HETE changes described above
VII Measure glutathione peroxidase GPx activity within the colon pre and post therapy as an indirect marker of reduced oxidative stress within the colonic epithelium
VIII Ensure safety of all participants during course of study investigation IX Determine the curcumin concentration in plasma before and after treatment
OUTLINE This is a multicenter nonrandomized uncontrolled study
Patients receive 1 of 2 doses of oral curcumin once daily Treatment continues for 30 days in the absence of unacceptable toxicity or disease progression
Blood and tissue biopsies are obtained by sigmoidoscopy or colonoscopy at baseline and at day 30 for correlative biomarker studies The change in prostaglandin E_2 PGE_2 is assessed by enzyme immunoassay 5-hydroxy-eicosatetraenoic acid 5-HETE by high-performance liquid chromatography cyclooxygenases COX-1 and COX-2 and 5-lipoxygenase 5-LOX by western blotting Ki-67 by immunohistochemistry and glutathione peroxidase GPx by spectrophotometric assay
After completion of study therapy patients are followed at 1 week
PROJECTED ACCRUAL A total of 48 patients 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-2013-00449 | REGISTRY | None | None |
| UIC-2005-0617 | None | None | None |
| CDR0000483003 | None | None | None |
| UCIRVINE-2005-4586 | None | None | None |
| UIC HS 2005-0617 | None | None | None |
| CCUM-HUM00000731 | None | None | None |
| P30CA062203 | NIH | None | None |
| 2005-0617 | OTHER | None | None |
| UCI04-2-01 | OTHER | None | None |
| N01CN35160 | NIH | DCP | httpsreporternihgovquickSearchN01CN35160 |