Clinical trial · Interventional
Curcumin Biomarker Trial in Head and Neck Cancer
An Exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® in Subjects With Newly Diagnosed Head and Neck Squamous Cell Carcinoma
NCT01160302CI-TRIAL-00021201completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microgranular Curcumin C3 Complex® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Microgranular Curcumin
- description
- Consume 4g microgranular curcumin (Curcumin C3 Complex) twice per day
- interventionNames
- Drug: Microgranular Curcumin C3 Complex®
Primary outcomes (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Subjects willing to undergo tumor biopsies * Subjects willing to refrain from nonsteroidal anti-inflammatory drugs (NSAIDS) * Eastern Co-operative Oncology Group (ECOG) status of 0-3 * Absolute Neutrophil Count ≥ 1500/mm³, Hgb ≥ 10g/dl and Platelet count ≥ 150,000 mm3 * 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 * Signed and dated institutional review board approved informed consent form before any protocol specific procedures are performed * 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 * No consumption of curcumin-rich foods to subject's knowledge within the previous 48 hours * Age ≥ 18 years to ≤ 90 years Exclusion Criteria: * Subjects receiving anticoagulation therapy * Known hypersensitivity to curry or black pepper * Prior cancer therapy in the last 30 day * Concurrent chemotherapy or radiation * Severely immunocompromised subjects * Subjects known to be HIV positive * any major illness that, in the investigator's judgment, will substantially increase the risk asociated with the subject's participation in the study * Pregnant or nursing women * Unwillingness or inability to comply with required study visits and procedures in this protocol
References
Publications (0)
Data not yet available
No reference posted for this study.