Clinical Study Evaluating the Efficacy and Safety of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis.
研究概览
简要总结
A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck 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
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults >18 years diagnosed with squamous cell carcinoma of the head and neck scheduled to receive curative radiotherapy (Primary or postoperative) of at least 50 Gy with or without concurrent chemotherapy.
- •Individuals with healthy mucosa.
- •Adequate bone marrow function (Hemoglobin level ≥10 g/dL, platelet count ≥75 × 103/microliter, and absolute neutrophil count ≥1.5 × 103/microliter).
- •Patients with ECOG performance ≤2
排除标准
- •History of chemotherapy or radiotherapy.
- •Signs of systemic infections.
- •Pregnant and lactating women.
- •Individuals receiving systemic analgesics.
- •Liver disorders and renal failure with eGFR <30 ml/min/1.73m2 (by the MDRD equation).
- •Inability to follow instructions and complete the questionnaires.
研究组 & 干预措施
Control arm
Standard Care
干预措施: Institutional standard care (Drug)
Interventional arm
Standard Care plus NAC
干预措施: N-Acetyl-Cysteine with Institutional standard care (Drug)
结局指标
主要结局
Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis.
时间窗: 8 weeks
Difference between the two arms regarding incidence of grade ≥ 2 according to World Health Organization scale for Oral Mucositis.
次要结局
- Duration of oral mucositis with grade ≥ 2.(8 weeks)
- Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4(8 weeks)
- Pain assessed by Visual Analog Scale (VAS).(8 weeks)
- Functional oral intake scale(8 weeks)
- Time to develop oral mucositis with grade ≥ 2.(8 weeks)
研究者
Noha Mansour
Lecturer of Clinical Pharmacy and Pharmacy Practice
Mansoura University