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
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Primary Objective is to Evaluate the Pain scores at baseline, post 1st dose of analgesic and at day 7
研究概览
简要总结
In this study 154 head and neck cancer patients undergoing radical or adjuvant chemoradiation, who have grade 1 or above mucositis ( in accordance with CTCAE version 5.0) and have pain related to it would be randomly assigned to either Gabapentin or tramadol for mucositis related pain control. Pain score would be noted at baseline (on Visual analogue scale), postfirst dose of analgesic and at day 7. The area under the curve (AUC) will be calculated with the pain scores been plotted on Y axis and time points been plotted on X axis. The time scale will be adjusted for baseline with scale 0 and the other the time scales would be replaced by a numerical scale of 1, 2, 3, 4, 5, and 6 to avoid overweighting the later time points.The AUCs for the two treatment arms will be compared by using the Wilcoxon rank sum test with 95% CIs.The primary endpoint comparison of change of analgesic at 1 week postrandomisation. The secondary endpoints of this study are comparison of analgesia post administration of the studied analgesic post first dose ,to compare the QOL, compliance and adverse events at end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
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
- •Normal haematological parameters a.Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused) 7.Normal Liver functions a.Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN-1.2 mg/dl) range and AST and ALT levels ≤ 2.5 × 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.
结局指标
主要结局
Primary Objective is to Evaluate the Pain scores at baseline, post 1st dose of analgesic and at day 7
时间窗: 1.Pain score at baseline (on Visual analogue scale) and first dose of analgesic and at day 7 would be noted.
次要结局
- To compare the rate of change or escalation of analgesic post 1 week of start of studied analgesic in the treatment of CTRT induced mucositis pain in patients with HNC.(1.To compare the rate of change or escalation of analgesic post 1 week of start of studied analgesic)
- To compare the QOL week 1 post randomisation andat the end of CTRT between the 2 arms(3.To compare the QOL week 1 post randomisation andat the end of CTRT between the 2 arms)
- To compare the compliance and adverse events(After completion of treatment)
- Treatment delay(After completion of treatment)