An Exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® in Subjects With Newly Diagnosed Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in tissue biomarkers
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Microgranular Curcumin
Consume 4g microgranular curcumin (Curcumin C3 Complex) twice per day
干预措施: Microgranular Curcumin C3 Complex® (Drug)
结局指标
主要结局
Change in tissue biomarkers
时间窗: 21-28 days
Change in tissue levels, between pre- and post-treatment biopsy
Pharmacokinetics of microgranular curcumin
时间窗: 21-28 days
Determine whether biologically active levels of curcumin can be achieved in head and neck tumors
次要结局
- Ease of ingestion(21-28 days)
研究者
Cherie Ann Nathan
Chairman, Dept of Otolaryngology
Louisiana State University Health Sciences Center Shreveport