COMPARISON Between TWO MOUTHWASHES in the Prevention and Management of ORAL MUCOSITIS During RADIOTHERAPY of HEAD AND NECK CANCER Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Salivary macrophage migratory inhibitory Levels
研究概览
简要总结
The goal of this clinical trial is to compare and correlate salivary macrophage migratory inhibitory factor levels with onset and severity of radiation induced mucositis in head and neck cancer patients by using super saturated calcium phosphate solution and benzydamine hydrochloride oral rinses. Participants are patients of head and neck cancers undergoing radiation therapy of either gender.
participants are divided into two groups Group A: Benzydamine group Group B: Super saturated calcium phosphate group
- Participants will be using Oral rinses of their respective group and will be assessed for radiation induced oral mucositis at weekly intervals during radiation treatment.
- salivary Macrophage migratory inhibitory factor levels will be assessed through ELISA, before and after the radiation treatment as per protocol.
详细描述
42 patients of either gender and age group 30-70 years with head and neck cancer will be selected. Informed consent will be obtained from all the patients (Annex-I, Annex-II). Selected patients will have no history of previous radiotherapy or any other major systemic disease. There will be no evidence of oral mucositis before the commencement of study. The patients will be assigned into two groups by non-probability convenient sampling and their study groups will be as follows:
Groups Number of patients Oral Rinse to be Used A 21 Benzydamine Hydrochloride B 21 Super saturated calcium phosphate solution Patients will be examined before starting radiotherapy. Radiation therapy will be started at a dose of 2 Gray per fraction for 5 days a week up to a total dose of 50-70 Grays in total 6 weeks.
In the experimental group1patients will be asked to rinse with 15 ml benzydamine hydrochloride solution for three times daily from the day radiation therapy will start till the radiation therapy continues (6 weeks).
In the experimental group 2 patients will be asked to rinse with 30 ml supersaturated calcium phosphate solution for four times daily from the day radiation therapy will start till the radiation therapy continues (6 weeks).supersaturated calcium phosphate solution will be prepared and dispensed(Annex III). It will be stored at room temperature.
Examination of oral mucosa will be performed on all patients at the beginning of treatment and will be continued weekly up to the end of radiotherapy (6 weeks) by visual assessment. Grade 0-4 of oral mucositis by WHO will be assessed using battery operated light.
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
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either gender (age group 30-70 years) with any histological type of head and neck cancers having a treatment plan to receive radiotherapy.
排除标准
- •Patients with poorly controlled diabetes mellitus
- •Patients with prior xerostomia
- •Patients with a history of chemo/radiotherapy
研究组 & 干预措施
Group A Benzydamine group
group A will use benzydamine oral rinses throughout their radiation treatment
干预措施: Benzydamine hydrochloride mouthrinse (Drug)
Group B super saturated calcium phosphate group
group B will use super saturated calcium phosphate oral rinses throughout their radiation treatment
干预措施: Super saturated calcium phosphate oral rinses (Drug)
结局指标
主要结局
Salivary macrophage migratory inhibitory Levels
时间窗: Two readings will be taken. 1st Baseline at day Zero (before start of radiotherapy) . 2nd at 3 weeks postradiotherapy.
Salivary macrophage migratory inhibitory Levels will be assessed before the start of radiotherapy and 3 weeks after the completion radiation therapy for each patient in both the groups
Grade of Oral mucositis.
时间窗: Assessment at day zero before start of radiotherapy. Assessment at week 1. Assessment at week 2. Assessment at week 3. Assessment at week 4. Assessment at week 5. Assessment at week 6, the end of radiotherapy.
Oral musocositis grade will be assessed in both groups at weekly interval.
次要结局
未报告次要终点
研究者
Humaira Batool
Post Graduate Resident
Postgraduate Medical Institute, Lahore