Efficacy of Topical Oral Omega-3 Hydrogel in Prevention of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Oral Mucositis Severity
研究概览
简要总结
Oral mucositis (OM) is recognized as one of the most frequent debilitating sequela encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of radiation-induced oral mucositis and secondarily, to test the effect of topical oral Omega-3 hydrogel on oral microbiome.
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
- None
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
- 否
入选标准
- •Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
- •Patients whose radiotherapy treatment planned dose is 50 Gy or above
- •Males and females with an age not less than 18 years
- •Patients receiving radiotherapy alone or receiving concomitant cisplatin (or carboplatin) with radiotherapy.
排除标准
- •Patients under Anticoagulants such as warfarin, heparin, or aspirin.
- •Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
- •Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.
研究组 & 干预措施
Topical oral Omega-3 hydrogel group
Patients will be given topical oral Omega-3 hydrogel
干预措施: topical oral Omega-3 hydrogel (Drug)
Conventional preventive treatment group
Patients will be given conventional preventive treatment
干预措施: conventional preventive treatment (Drug)
结局指标
主要结局
Oral Mucositis Severity
时间窗: up to 6 weeks
Radiation induced head and neck toxicity will be scored by a scale based on clinical features from Common Terminology Criteria for Adverse Events (CTCAE) v5.0
次要结局
未报告次要终点
研究者
Basma Morsy
Principal Investigator
Alexandria University