CTRI/2020/03/024269尚未招募3 期
A randomized study to evaluate the effectiveness of Gabapentin on Oral-Mucositis induced pain due to chemo-radio therapy in patients with head and neck cancers.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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
- •1.Age 18 to 70-years
- •2.Histologically or cytologically confirmed head and neck cancers receiving CTRT
- •3.Presence of radiation induced mucositis grade 1 or above
- •4.Pain related to mucositis on Visual analogue scale of 1 or more
- •5.ECOG PS 0-2
- •6. Normal haematological parameters
- •a.Hematologic: Absolute neutrophil count (ANC) >= 1.5 Ã? 109/L, platelet count >= 100 Ã? 109/L, and hemoglobin >= 9 g/dL (may have been transfused)
- •7.Normal Liver functions
- •a.Total bilirubin level <= 1.5 Ã? the upper limit of normal (ULN-1.2 mg/dl) range and AST and ALT levels <= 2.5 Ã? ULN ( AST/ALT <50 U/L)
排除标准
- •1.Use of analgesic for more than 1 week X
- •2.Deranged serum creatinine > 1.5ULN
- •3.Known allergy to tramadol
研究者
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