Curcumin in Preventing Colorectal Cancer in Patients Unde... | NCT00973869

Studies
Curcumin in Preventing Colorectal Cancer in Patients Undergoing Colorectal Endoscopy or Colorectal Surgery

NCT00973869

Sponsor

University of Leicester

Status

Unknown status

Last Update Posted

Jun 24, 2014Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Colorectal Cancer

Interventions

curcumin
high performance liquid chromatography
laboratory biomarker analysis
pharmacological study
diagnostic endoscopic procedure
therapeutic conventional surgery

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jan 2010Estimated

Completion Date

Not provided

First Submitted Date

Sep 5, 2009

First Submission Date that Met QC Criteria

Sep 5, 2009

First Posted Date

Sep 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2014

Last Update Posted Date

Jun 24, 2014Estimated

Description Module

Brief Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of curcumin may prevent or treat colorectal cancer.

PURPOSE: This phase I trial is studying the side effects of curcumin in preventing colorectal cancer in patients undergoing colorectal endoscopy or colorectal surgery.

Detailed Description

OBJECTIVES:

Primary

To determine levels of curcumin and its metabolites in normal colorectal tissue in patients undergoing colorectal endoscopy or colorectal cancer surgery following a 14-day course of curcumin.

Secondary

To assess the practicality, acceptability, and safety of administering 5 capsules of curcumin daily for 14 days.
To check the presence of curcumin and its metabolites in peripheral blood and urine.

OUTLINE: Patients receive oral curcumin once daily for 14-28 days. Patients then undergo colorectal endoscopy or resection.

Normal colorectal tissue samples are collected via biopsy for curcumin assay after the last dose of curcumin. Patients also undergo blood and urine sample collection at baseline and after the last dose of curcumin for pharmacokinetic analysis by high performance liquid chromatography.

After completion of study treatment, patients are followed up at 14 days.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
curcumin	Dietary Supplement
high performance liquid chromatography	Other
laboratory biomarker analysis	Other
pharmacological study	Other
diagnostic endoscopic procedure	Procedure
therapeutic conventional surgery	Procedure

Measure	Description	Time Frame
Concentration of curcumin in colorectal tissue after treatment

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Meets 1 of the following criteria:
- Has a positive fecal occult blood test found during a pilot colorectal cancer screening program
- Awaiting diagnostic or surveillance colonoscopy
- Diagnosis of colorectal cancer

PATIENT CHARACTERISTICS:

Able to return for follow-up tests
Fertile patients must use effective contraception
No discrete gastric or duodenal ulcer > 5 mm in the past year
- Patients with a history of Helicobacter pylori-related peptic ulcer disease are eligible after successfully completing antibiotic treatment for Helicobacter pylori
No significant medical or psychiatric problem, including significant renal, hepatic, or hematological dysfunction, that would make the patient a poor candidate for this study

PRIOR CONCURRENT THERAPY:

More than 3 months since prior investigational agents
No prior pelvic radiotherapy
No other concurrent investigational agents

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
William P. Steward, MD, PhD	University Hospitals, Leicester	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
St. Mark's Hospital	Recruiting	Harrow	England	HA1 3UJ	United Kingdom

ID	Term
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms
D012004	Rectal Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D003474	Curcumin
D002851	Chromatography, High Pressure Liquid

Ancestor Terms

ID	Term
D036381	Diarylheptanoids
D006536	Heptanes
D000473	Alkanes
D006839	Hydrocarbons, Acyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D002396	Catechols
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D002853	Chromatography, Liquid
D002845	Chromatography
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

ID	Type	Description	Link
LRI-UL-CURCUMIN
EUDRACT-2007-001971-13
EU-20961

Measure	Description	Time Frame
Tolerability and compliance
Presence of curcumin and its metabolites in peripheral blood and urine