CTRI/2008/091/000193Other2 期
An invivo study to evaluate the role of curcumin in oral pre-malignant lesions and gingivo-buccal cancers
试验速览
- 阶段
- 2 期
- 状态
- Other
- 发起方
- DBT
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •? Age > 18 years
- •? Histologically confirmed resectable oral cavity cancer (T3, T4a) with a co-existent premalignant condition i.e. leukoplakia or submucous fibrosis.
- •? Gives informed consent
- •? Previously untreated
- •? WHO performance status of < 1
- •? Laboratory values (performed within 14 days prior to administration of Curcumin)
- •? WBC count > 3.0 x 109 /L
- •? Platelet count ≥ 150 x 109 /L
- •? Hemoglobin ≥ 10 gm/dl (100 gm/l)
- •? Serum creatinine less than 1.5 times the upper normal limit
- •? Total bilirubin less than 1.5 times the upper normal limit
- •? SGOT or SGPT ≤ 5.0 times upper limit of normal
- •? Negative Pregnancy test (female patients of childbearing potential only)
排除标准
- •? The patient is < 18 years or >75 years of age
- •? The patient has had chemotherapy, immunotherapy, hormonal therapy, or radiation therapy within 4 weeks of the baseline visit
- •? The patient will need concurrent chemotherapy, radiotherapy, hormonal (other than HRT for menopause), or immunotherapy during the time of study
- •? The patient has history of any form of cancer within the past three years (excluding non-melanoma skin cancer and in situ cervical cancer)
- •? The patient has received any investigational medication within 30 days of starting the curcumin therapy
- •? The patient is participating in any other study
研究者
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