Assessing the Effects and Safety of MEBO as Add on Therapy for the Prevention of Radiotherapy-Induced Mucositis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Oral mucositis Severity
研究概览
简要总结
Radiation therapy (RT) is used in at least 50% of cancer patients and is critical in treating and palliating tumor-related symptoms. Normal tissue radiation toxicity remains an overwhelming obstacle in treating cancer patients with localized tumors.
Mucositis is the inflammation and ulceration of the oral and gastrointestinal mucosa observed with different cancer therapies. Oral mucositis is a common, severe, and debilitating complication of RT occurring several days to weeks after RT initiation.
详细描述
This study is a single blind randomized controlled clinical trial with a parallel-group design conducted in the clinical oncology department of Beni-Suef University Hospital.
A total of 50 patients with head and neck cancer receiving RT were randomly assigned into either study group:
Group 1 (Intervention group):
This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks
Group 2 (Control group):
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18 years) with histopathologically confirmed Head and Neck Cancer (HNC), primary tumor in the stages T1, T2, T3, or T4, a regional node of any N status, and distant metastases absent.
- •All patients who were going to receive RT (dose between 60-70 Gy) on the head and neck region as postoperative (adjuvant) or definitive therapy. Either these patients had received chemotherapy prior or in concomitant to radiotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2 and normal hematologic and biochemical parameters.
排除标准
- •patients undergoing previous radiotherapy
- •uncontrolled systemic or widely disseminated disease
- •having any physical or mental abnormality,
- •pregnant and lactating women
- •presence of a synchronous double primary malignancy or simultaneous participation in another clinical trial
研究组 & 干预措施
MEBO ointment + symptomatic therapy
This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks.
干预措施: MEBO ointment (Drug)
MEBO ointment + symptomatic therapy
This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks.
干预措施: Symptomatic treatment only (Drug)
symptomatic therapy
This group included twenty-five patients given symptomatic therapy 3 times daily for 7 weeks.
These therapies included anti-fungal agents (Miconaz oral gel), topical anesthetics and anti-inflammatory drugs (BBC oral spray), topical analgesic gel (Oracure gel), sodium bicarbonate mouthwash (Alkamisr sachets).
干预措施: Symptomatic treatment only (Drug)
结局指标
主要结局
Oral mucositis Severity
时间窗: 7 weeks
Oral mucositis severity was measured by the World Health Organization Toxicity Scale (WHO grading system) Grade 1 Mild; asymptomatic Grade 2 Moderate; minimal, local inflammation Grade 3 Severe or medically significant Grade 4 Life-threatening Grade 5 Death
次要结局
- Dry mouth, Dysphagia score(7 weeks)
- Discomfort and pain severity(7 weeks)
研究者
Asmaa Abdelfattah Elsayed
Lecturer of clinical pharmacy
Beni-Suef University