Effectiveness of Topical Olive Oil in Prevention and Management of Radiation Induced Oral Mucositis: a Randomised Clinical Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of Oral Radiation mucositis
研究概览
简要总结
This research aims to investigate the effectiveness of topical olive oil application both clinically and biochemically as a suitable affordable treatment modality for prevention and management of radiation oral mucositis and its associated pain for head and neck cancer patients receiving radiotherapy.
详细描述
Twenty adult patients seeking radiotherapy treatment for head and neck cancer are to be selected. Patients meeting the eligibility criteria are to be equally and randomly allocated in 2 different groups. Group 1 will include10 patients receiving topical olive oil application, twice daily (Experimental arm). Group 2 will include 10 patients receiving Sodium bicarbonate 5% solution, twice daily (Control arm). Both intervention and control groups will start the application of the agents two days before the induction of radiotherapy. Evaluation will be done using World Health Organization (WHO) scale for oral mucositis to record the extent and severity of oral mucositis. Pain and discomfort will be evaluated using Numeric Rating Scale (NRS). Clinical evaluation using both scales will be performed after starting radiotherapy every other week ( after 2 weeks, after 4 weeks and after 6 weeks at the end of the treatment). Patients scores will be recorded at similar intervals. Total Antioxidant Capacity "TAC" will be used to study the biochemical effect of topical olive oil application by evaluating the oxidative stress in the saliva. Saliva samples will be collected from all patients of both groups prior to the beginning of radiotherapy, and a second sample will be collected after six weeks.
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are aged above 25 years up to 65 years.
- •Both genders are eligible.
- •Patients with head and neck cancer who are planned to receive radiotherapy either as postoperative (adjuvant after surgery) or definitive therapy.
- •Patients planned to receive radiotherapy treatment with a dose of 60-70 Gy.
排除标准
- •Patients with known sensitivity to olive oil and/or any of its products
- •Patients with gingival or oral ulceration or mucositis
- •Vulnerable patients (pregnant women, neonates, children, prisoners, persons with physical handicaps or mental disabilities)
- •Pregnant and lactating women.
- •Patients with any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
- •Patients suffering from any physical or mental disabilities that would interfere with or be affected by the study procedure.
结局指标
主要结局
Incidence of Oral Radiation mucositis
时间窗: Every other week ( 2 weeks, 4 weeks and 6 at the end of the treatment)
Number of participants who develop Radiation mucositis according to the WHO Scale. (grade 0 indicates that no changes have occurred in the oral cavity and grade 4 indicates the worst level of mucositis )
Grade of oral radiation mucositis
时间窗: Every other week ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment)
Clinical evaluation using the WHO scale will be performed to record the changes in the oral cavity after starting radiotherapy, (grade 0 indicates that no changes have occurred in the oral cavity and grade 4 indicates the worst level of mucositis )
次要结局
- Total antioxidant capacity(Salivary samples will be collected at baseline before the induction of radiotherapy and at 6 weeks at the end of the treatment for TAC analysis.)
- Post operative pain assessment using Numeric Pain Rating Scale(Patients scores will be recorded after starting radiotherapy every other week ( 2 weeks, 4 weeks and 6 weeks at the end of the treatment))
研究者
Salma Hesham Elhoufi
Principal Investiagtor
Ain Shams University