Prevention of Radiotherapy Induced Xerostomia by Intraductal Administration of N-Acetyl Cysteinein Patients with Oropharyngeal Malignancies: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference in severity grading of xerostomia according to RTOG EORTC scoring system
研究概览
简要总结
Oropharyangeal cancer constitutes a substantial proportion of head and neck cancers and is prevalent worldwide including India. Radiotherapy-induced xerostomia (RIX) occurs in around 70 percent of the cases undergoing radiation therapy. The symptoms affect the quality of life of the patients considerably and no therapy has been proven reasonably effective to prevent or treat the complication. The complications arise due to proximity of the salivary glands to the target affected tissue. Evidence suggests that such damage occurs due to free radicals generated by radiotherapy which on one hand kills the tumor tissues while also collaterally damaging the salivary glands.
This study will use a well-established antioxidant which is considered safe i.e. N-Acetyl cysteine (NAC). It has free radical scavenging property to prevent the free radical induced injury to salivary glands. The local use of NAC will likely prevent this collateral damage in disease free glands. If the results are gained as expected, the therapy would stand to be safe, effective and cheap as a preventive measure against RIX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated 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
- •Patients of oropharyngeal carcinoma
- •Either gender with age between 18-70 years (both inclusive)
- •Planned for radical external beam radiotherapy.
排除标准
- •Patients with decreased mouth opening
- •A coexisting disease causing xerostomia
- •Revision cases
- •Denial for consent.
结局指标
主要结局
Difference in severity grading of xerostomia according to RTOG EORTC scoring system
时间窗: 2 weeks, 3 months, 6 months and 1 year
次要结局
- Quantity (in ml) of stimulated saliva(2 weeks, 3 months, 6 months and 1 year)
- pH and viscosity of and IgA levels in saliva(2 weeks, 3 months, 6 months and 1 year)
- Change in quality of life(2 weeks, 3 months, 6 months and 1 year)
