A randomised controlled trial to assess the effect of ‘oral ice application’ in preventing mucositis associated with radiotherapy among cancer patients undergoing radiotherapy at regional cancer centre, PGIMER, Chandigarh 2012-13.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Delay in the development of oral mucositis was also noted in the interventional group as compared to control group
研究概览
简要总结
Abstract Background: Oral mucositis is a common side effect of radiotherapy. No effective intervention reported for its prevention and management. The goal of this study was to assess the effect of ‘oral ice application’ for the prevention of radiotherapy associated mucositis. Methods: The present study was carried out in the Radiotherapy unit of Regional Cancer Centre, PGIMER, Chandigarh over a period of six months. In this randomized controlled trial, newly diagnosed head and neck cancer patients undergoing radical radiotherapy were allocated into experimental and the control groups of 30 patients each. The patients in the experimental group were asked to hold ice cube in mouth for 4 minutes before and after radiotherapy along with routine care till the completion of their treatment. And the patients in control group were continued with routine care. Oral mucositis was assessed on 1st, 5th, 10th, 15th, and 20th day of radiotherapy by using WHO oral toxicity scale. Data analysis was done by using chi square test and Fisher’s exact test at 0.05 level of significance. Results: Majority (93%) of the subjects was males and 70% of the subjects were having the habit of smoking before beginning the treatment. Grade 1 mucositis reported in experimental group on 10th day of the treatment. But in control group it was noted on 5th day. After the intervention, a significant lower incidence of mucositis was found in experimental group on 10th day of treatment (p< 0.05). Grade 3 mucositis was reported only in the control group on 20th day (p>0.05). Conclusions: This study shows that ‘oral ice application’ was useful for delaying the mucositis and reducing the severity of mucositis. However further studies are essential to confirm this observation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males or females diagnosed with head and neck cancer and planned for radical radiotherapy and having normal mucosa.
排除标准
- •Patients diagnosed with head and neck cancer and planned for palliative radiotherapy.
- •Patients who are coming for booster dose of radiation.
结局指标
主要结局
Delay in the development of oral mucositis was also noted in the interventional group as compared to control group
时间窗: Oral mucositis was assessed on 1st day of radiotherapy prior to treatment, | On end of 1st week of treatment i.e. on 5th day of the treatment, | On end of 2nd week of treatment i.e. on 10th day of the treatment, | On end of 3rd week of treatment i.e. on 15th day of the treatment, | On end of 4th week of treatment i.e. on 20th day of the treatment.
Oral mucositis was assessed with the help of WHO oral toxicity scale and Low grade of mucositis was observed in interventional group as comparing with control group.
时间窗: Oral mucositis was assessed on 1st day of radiotherapy prior to treatment, | On end of 1st week of treatment i.e. on 5th day of the treatment, | On end of 2nd week of treatment i.e. on 10th day of the treatment, | On end of 3rd week of treatment i.e. on 15th day of the treatment, | On end of 4th week of treatment i.e. on 20th day of the treatment.
次要结局
- Effect of ice application on tumour size and response(Follow up visits by the patient. But this was not conducted due to limited time period)