Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT01160302
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01160302
Study Brief:
Protocol Section:
NCT01160302