Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT01160302
Status:
COMPLETED
Last Update Posted:
2016-03-02
First Post:
2010-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Curcumin Biomarker Trial in Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-01', 'studyFirstSubmitDate': '2010-07-08', 'studyFirstSubmitQcDate': '2010-07-08', 'lastUpdatePostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in tissue biomarkers', 'timeFrame': '21-28 days', 'description': 'Change in tissue levels, between pre- and post-treatment biopsy'}, {'measure': 'Pharmacokinetics of microgranular curcumin', 'timeFrame': '21-28 days', 'description': 'Determine whether biologically active levels of curcumin can be achieved in head and neck tumors'}], 'secondaryOutcomes': [{'measure': 'Ease of ingestion', 'timeFrame': '21-28 days', 'description': 'Determine if microgranular curcumin can be easily ingested'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cancer'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'There is considerable evidence that turmeric consumption may have a protective effect against cancer progression. The purpose of this study is to examine the short-term effects of supplementation with a turmeric extract, Curcumin C3 Complex®, on biomarkers of head and neck squamous cell carcinoma (HNSCC).', 'detailedDescription': 'This is an open label, exploratory biomarker trial of the food substances Curcumin C3 Complex® in subjects with newly diagnosed HNSCC. Curcumin, a novel safe nutritional interventional agent has exciting potential usage as a preventive/adjuvant agent, and prevents tumor formation by inhibiting an important molecular pathway that is shown to cause cancer progression, which we will test as a tumor marker in this clinical trial.\n\nThe primary objective is to evaluate biomarker response of HNSCC patients to the food substances Curcumin C3 Complex®. This will be done by comparing post-intervention values to baseline values. In addition, we will determine the levels of curcumin and its metabolites in tumor and adjacent tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with newly diagnosed head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx and have at least one accessible tumor\n* Subjects willing to undergo tumor biopsies\n* Subjects willing to refrain from nonsteroidal anti-inflammatory drugs (NSAIDS)\n* Eastern Co-operative Oncology Group (ECOG) status of 0-3\n* Absolute Neutrophil Count ≥ 1500/mm³, Hgb ≥ 10g/dl and Platelet count ≥ 150,000 mm3\n* Adequate Renal Function: serum creatinine ≤ 1.5 × upper limit of normal (ULN). Adequate hepatic function: total bilirubin ≤ 1.5 × ULN, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.0 × ULN\n* Signed and dated institutional review board approved informed consent form before any protocol specific procedures are performed\n* Willingness of subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study and for 2 weeks after last dose of study drug\n* No consumption of curcumin-rich foods to subject's knowledge within the previous 48 hours\n* Age ≥ 18 years to ≤ 90 years\n\nExclusion Criteria:\n\n* Subjects receiving anticoagulation therapy\n* Known hypersensitivity to curry or black pepper\n* Prior cancer therapy in the last 30 day\n* Concurrent chemotherapy or radiation\n* Severely immunocompromised subjects\n* Subjects known to be HIV positive\n* any major illness that, in the investigator's judgment, will substantially increase the risk asociated with the subject's participation in the study\n* Pregnant or nursing women\n* Unwillingness or inability to comply with required study visits and procedures in this protocol"}, 'identificationModule': {'nctId': 'NCT01160302', 'briefTitle': 'Curcumin Biomarker Trial in Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center Shreveport'}, 'officialTitle': 'An Exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® in Subjects With Newly Diagnosed Head and Neck Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'H08-081'}, 'secondaryIdInfos': [{'id': '1R21CA137545-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1R21CA137545-01A2', 'type': 'NIH'}, {'id': 'FWCC', 'type': 'OTHER', 'domain': 'Feist-Weiller Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microgranular Curcumin', 'description': 'Consume 4g microgranular curcumin (Curcumin C3 Complex) twice per day', 'interventionNames': ['Drug: Microgranular Curcumin C3 Complex®']}], 'interventions': [{'name': 'Microgranular Curcumin C3 Complex®', 'type': 'DRUG', 'description': '4 grams twice daily for 21-28 days', 'armGroupLabels': ['Microgranular Curcumin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71130', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSUHSC-Shreveport and Feist-Weiller Cancer Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}], 'overallOfficials': [{'name': 'Cherie-Ann O Nathan, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LSUHSC-Shreveport and Feist-Weiller Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louisiana State University Health Sciences Center Shreveport', 'class': 'OTHER'}, 'collaborators': [{'name': 'Feist-Weiller Cancer Center at Louisiana State University Health Sciences', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman, Dept of Otolaryngology', 'investigatorFullName': 'Cherie Ann Nathan', 'investigatorAffiliation': 'Louisiana State University Health Sciences Center Shreveport'}}}}