Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-30 @ 10:04 AM
Study NCT ID:
NCT00973869
Status:
UNKNOWN
Last Update Posted:
2014-06-24
First Post:
2009-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Curcumin in Preventing Colorectal Cancer in Patients Undergoing Colorectal Endoscopy or Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}, {'id': 'D002851', 'term': 'Chromatography, High Pressure Liquid'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D002853', 'term': 'Chromatography, Liquid'}, {'id': 'D002845', 'term': 'Chromatography'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'lastUpdateSubmitDate': '2014-06-23', 'studyFirstSubmitDate': '2009-09-05', 'studyFirstSubmitQcDate': '2009-09-05', 'lastUpdatePostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of curcumin in colorectal tissue after treatment'}], 'secondaryOutcomes': [{'measure': 'Tolerability and compliance'}, {'measure': 'Presence of curcumin and its metabolites in peripheral blood and urine'}]}, 'conditionsModule': {'keywords': ['colon cancer', 'rectal cancer'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of curcumin may prevent or treat colorectal cancer.\n\nPURPOSE: This phase I trial is studying the side effects of curcumin in preventing colorectal cancer in patients undergoing colorectal endoscopy or colorectal surgery.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n\nSecondary\n\n* To assess the practicality, acceptability, and safety of administering 5 capsules of curcumin daily for 14 days.\n* To check the presence of curcumin and its metabolites in peripheral blood and urine.\n\nOUTLINE: Patients receive oral curcumin once daily for 14-28 days. Patients then undergo colorectal endoscopy or resection.\n\nNormal 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.\n\nAfter completion of study treatment, patients are followed up at 14 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Meets 1 of the following criteria:\n\n * Has a positive fecal occult blood test found during a pilot colorectal cancer screening program\n * Awaiting diagnostic or surveillance colonoscopy\n * Diagnosis of colorectal cancer\n\nPATIENT CHARACTERISTICS:\n\n* Able to return for follow-up tests\n* Fertile patients must use effective contraception\n* No discrete gastric or duodenal ulcer \\> 5 mm in the past year\n\n * Patients with a history of Helicobacter pylori-related peptic ulcer disease are eligible after successfully completing antibiotic treatment for Helicobacter pylori\n* No significant medical or psychiatric problem, including significant renal, hepatic, or hematological dysfunction, that would make the patient a poor candidate for this study\n\nPRIOR CONCURRENT THERAPY:\n\n* More than 3 months since prior investigational agents\n* No prior pelvic radiotherapy\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00973869', 'briefTitle': 'Curcumin in Preventing Colorectal Cancer in Patients Undergoing Colorectal Endoscopy or Colorectal Surgery', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Pilot Study of Administration of Curcumin to Determine Colonic Curcumin Tissue Levels in Patients Awaiting Colorectal Endoscopy or Patients With Colorectal Cancer Awaiting Resection', 'orgStudyIdInfo': {'id': 'CDR0000648267'}, 'secondaryIdInfos': [{'id': 'LRI-UL-CURCUMIN'}, {'id': 'EUDRACT-2007-001971-13'}, {'id': 'EU-20961'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'curcumin', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'high performance liquid chromatography', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'pharmacological study', 'type': 'OTHER'}, {'name': 'diagnostic endoscopic procedure', 'type': 'PROCEDURE'}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA1 3UJ', 'city': 'Harrow', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-20-8235-4225'}], 'facility': "St. Mark's Hospital", 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'William P. Steward, MD, PhD', 'role': 'CONTACT', 'email': 'wps1@le.ac.uk', 'phone': '44-116-258-7597'}], 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'overallOfficials': [{'name': 'William P. Steward, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals, Leicester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leicester', 'class': 'OTHER'}}}}