Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Treatment of Radiation Induced Oral Mucositis A Randamized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1) Mucositis score
研究概览
简要总结
Background and Rationale Oral mucositis (OM) is one of the most debilitating toxic side effects of radiotherapy and chemotherapy. ]Radiation-induced OM occurs due to the generation of free radicals, which induce mitochondrial dysfunction resulting in increased oxidative stress, DNA damage and cell apoptosis. Epidermal growth factor (EGF) levels were decreased in patients with severe OM, and patients with lower levels of EGF prior to therapy may indicate increased risk of mucosal damage during RT
Objectives:
The purpose of this study is for Evaluation of the efficacy of aloe-vera gel versus standard treatment as a new option in the treatment of radiation-induced oral mucositis
Study population & Sample size :
40 patient proven to have Head and neck cancer , requiring radiotherapy.
Study Design:
RCT. The patients are randomized and divided into 2 groups , group A will use alovera gel , Group B will use benzylamide gel, EGF will be measured in saliva before and after 4 weeks treatment Methods Patient's visits will be at baseline, 2 weeks and 4 weeks. At follow up visits patients will be instructed to bring back the consumed container to check that they had totally consumed their previous supply before giving them the new one. Saliva collection to measure EGF by ELIZA
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will include patients who are diagnosed with radiation-induced oral mucositis with any of its grades as scored by the world health organization (WHO) oral mucositis grading scale.
排除标准
- •patients under the age of 18 ,patients receiving any previous treatment for oral mucositis during the last 2 weeks, allergy to aloe-vera, patients with chronic liver disease, infectious diseases (HIV, HBV,HCV,....), immune system dysfunction, haematological diseases and pregnancy or breast-feeding
研究组 & 干预措施
intervention group: Aloe vera gel
干预措施: Aloe vera gel (Drug)
control group: enzydamine gel
干预措施: Benzydamine Hydrochloride 0.15% Oral gel (Drug)
结局指标
主要结局
1) Mucositis score
时间窗: 0, 2 weeks , weeks, 6 weeks and 10 weeks
1) Mucositis score which was recorded and graded as recommended by WHO . The grading criteria are as follows: grade 0 - no changes; grade I - soreness/(+)erythema; grade II - erythema (++), ulcer, can eat food(erythema with ulcers less than 1 cm2); grade III - ulcer(+++), (erythema with ulcers more than 1 cm2), requires liquid food; and grade IV - ulcer with haemorrhage and necrosis, alimentation not possible.
pain score
时间窗: 0, 2,4,6, and 10 weeks
2) Pain was recorded recommended by the Lindquist/Hickey scale 0 (none)- no pain; 1 (mild) - slight burning; 2 (moderate) - oral pain but able to eat; and 3 (severe) - severe pain and unable to eat.
次要结局
未报告次要终点
研究者
Amira Abdelwhab
lecturer of oral medicine, diagnosis and periodontology
October 6 University