Effectiveness of N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in pain scores
研究概览
简要总结
Background: Radiotherapy appears to be one of the most effective therapies in head and neck tumors, however, there are a lot of complications related to it. Oral Mucositis is one of the most common complications following radiotherapy. There are currently huge unmet needs for management of oral mucositis. It causes severe pain, reduces food intake and affects quality of life of the head and neck cancer patients .N-acetylcysteine (NAC) is a glutathione precursor which has an antioxidant property and protects against radiation therapy-induced free radical damage. NAC reduces the production of inflammatory markers which leads to decrease inflammation, treats oral mucositis and enhances quality of life of the patient. Aim: To evaluate the effectiveness of N-acetylcysteine and its formulated nanoparticles in treatment of radiotherapy induced oral mucositis in oral cancer patients .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with oral cancer by incisional biopsy histological examination.
- •Patients above the age of 20 years.
- •Patients receiving radiotherapy either as postoperatory (adjuvant) or as a definitive therapy in the treatment for oral cancer.
- •Patients with radiotherapy induced-oral mucositis.
- •Radiation dose ≥ 60 Gy which is responsible for oral mucositis development in oral cancer patients.
排除标准
- •Patients diagnosed with any other type of cancer.
- •Patients with any systemic disease as diabetes, cardiovascular, liver disorders and kidney disorders.
- •Patients under anticoagulants such as warfarin, heparin or aspirin.
- •Patients with findings of any physical or mental abnormalities
研究组 & 干预措施
Test Group
干预措施: N-acetylcysteine (NAC) spray (Drug)
Control Group
干预措施: Conventional treatment (Drug)
结局指标
主要结局
Change in pain scores
时间窗: Baseline,1,2,4,6 weeks
The Numerical Rating Scale (NRS-11):- where patients are asked to rate their pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst possible pain
change in oral mucositis severity
时间窗: Baseline and 6 weeks
Oral mucositis assessment scale (OMAS ) will be used to detect severity of oral mucositis at different mucosal sites in cm2 For each site, erythema is graded from 0 to 2 (none to severe), and ulceration/pseudomembrane formation is graded from 0 to 3 (none to \>3 cm²).
次要结局
- Change in patient quality of life(Baseline and 6 weeks)
- Serum gastrin 17(Baseline and 6 weeks)
研究者
Hams Hamed Abdelrahman
Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University