The Effectiveness of Topical Oral Vitamin D Gel in Prevention of Radiation-induced Oral Mucositis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Changes in severity of oral mucositis at different time points along the study
研究概览
简要总结
The main aim of this study was to evaluate clinically the effect of topical oral vitamin D gel in comparison to conventional therapy in prevention of radiation - induced oral mucositis
详细描述
The study was designed as randomized, controlled, clinical trial. patients who were undergoing to receive radiotherapy were divided into three groups: Group I: was given conventional treatment.Group II : was given topical oral gel of vitamin D. Group III: was given topical oral gel of vitamin D in combination with the conventional treatment.
All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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.
- •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 whose radiotherapy treatment planned dose is lower than 50 Gy.
- •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.
- •Hyper-calcemic patients.
研究组 & 干预措施
vitamin D oral gel
Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks.
Topical oral Vitamin D gel is prepared with the aid of pharmaceutics department, faculty of pharmacy, Alexandria University. It is prepared by using Cholecalciferol 2ml ampoule (200.000 I.U.) within topical oral gel formulation.
干预措施: vitamin D oral gel (Drug)
conventional therapy
Conventional therapy (symptomatic treatment) which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Dose: Three times a day for six weeks
干预措施: Miconazole Topical Gel (Drug)
conventional therapy
Conventional therapy (symptomatic treatment) which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Dose: Three times a day for six weeks
干预措施: BBC oral spray (Drug)
conventional therapy
Conventional therapy (symptomatic treatment) which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Dose: Three times a day for six weeks
干预措施: Oracure gel (Drug)
conventional therapy
Conventional therapy (symptomatic treatment) which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Dose: Three times a day for six weeks
干预措施: Alkamisr sachets (Other)
combination therapy
Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks in combination with the symptomatic treatment
Symptomatic treatment which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Symptomatic treatment dose: Three times a day for six weeks
干预措施: vitamin D oral gel (Drug)
combination therapy
Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks in combination with the symptomatic treatment
Symptomatic treatment which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Symptomatic treatment dose: Three times a day for six weeks
干预措施: Miconazole Topical Gel (Drug)
combination therapy
Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks in combination with the symptomatic treatment
Symptomatic treatment which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Symptomatic treatment dose: Three times a day for six weeks
干预措施: BBC oral spray (Drug)
combination therapy
Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks in combination with the symptomatic treatment
Symptomatic treatment which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Symptomatic treatment dose: Three times a day for six weeks
干预措施: Oracure gel (Drug)
combination therapy
Topical oral vitamin D gel twice daily (Equivalent to 8000 I.U/day vitamin D) for six weeks in combination with the symptomatic treatment
Symptomatic treatment which included:
- Miconaz oral gel
- BBC oral spray
- Oracure gel
- Alkamisr sachets
Symptomatic treatment dose: Three times a day for six weeks
干预措施: Alkamisr sachets (Other)
结局指标
主要结局
Changes in severity of oral mucositis at different time points along the study
时间窗: up to 3 and 6 weeks
Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third and sixth week after the first radiotherapy session.
次要结局
- Pain and discomfort severity at different time points along the study: Numeric Rating Scale(up to 3 and 6 weeks)
研究者
Hams Hamed Abdelrahman
Assistant lecturer
Alexandria University