Curcumin Biomarker Trial in Head and Neck Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | June 2010 |
| End Date: | January 2016 |
An Exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® in Subjects With Newly Diagnosed Head and Neck Squamous Cell Carcinoma
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).
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).
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.
The 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.
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.
The 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.
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
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