A Phase III Study of Magic Mouthwash Plus Sucralfate Versus Benzydamine HCl for Treatment of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- The severity of patient-reported symptoms of mucositis as determined by the change in Oral Mucositis Weekly Questionnaire - Head and Neck Cancer (OMWQ-HN) score from baseline to 6 weeks.
研究概览
简要总结
Radiation treatment is very effective for treating cancers of the head and neck, however, during the course of treatment, it is common for patients to experience soreness of their mouth and throat due to the radiation. When radiation causes inflammation of the inside of the mouth, it is called 'mucositis'. There are several mouthwashes that are commonly used to prevent and treat mucositis, but none of these have been shown to be superior to another. This study is being conducted to see if using a combination of magic mouthwash and sucralfate is better than using a single mouthwash called benzydamine at decreasing the burden of mucositis.
详细描述
Sixty patients with head and neck cancer being treated with 6 or more weeks of radiotherapy, will be randomly assigned to receive either a combination of magic mouthwash (diphenhydramine, dexamethasone and nystatin) plus sucralfate or benzydamine. Patients randomized to receive magic mouthwash plus sucralfate will rinse first with 5ml of the magic mouthwash for 2 minutes then swallow, followed by rinsing with 5ml of the 1g/5ml sucralfate for 2 minutes before swallowing, 4 times daily. Patients randomized to receive 0.15% benzydamine HCl will be instructed to rinse with 15ml of the solution for 2 minutes before expectorating, 4 times daily. Patients will start the mouthwash regimens prior to the initiation of radiotherapy, and stop 2 weeks after the completion of radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Histologically proven squamous cell carcinoma of the head and neck.
- •Receiving 6 or more weeks of external beam radiotherapy to a treatment volume that includes mucosal surfaces of the head and neck.
排除标准
- •Age less than 18 years
- •ECOG Performance Score 2 or higher
- •Patient is unable to understand the protocol and/or unable to provide informed consent
- •Patient is unable or unwilling to complete the questionnaires which are written in English.
- •Prior radiation to the head and neck region that would result in overlap of fields for the current study.
- •Plan to receive a radiation treatment volume that only includes the larynx and or hypopharynx with no planned treatment of locoregional lymph nodes.
- •Plan to receive a concurrent chemotherapy agent other than cisplatin.
- •Plan to receive other investigational agents (eg. panitumumab).
- •Investigational agent of any kind within 30 days prior to randomization.
- •Concurrent administration of any other experimental intervention given for the purpose of preventing oral mucositis.
- •History of allergic or hypersensitivity reactions to any of the possible agents to be administered in the study.
- •Patients who are pregnant or lactating.
研究组 & 干预措施
Magic Mouthwash Plus Sucralfate
干预措施: Combination of Magic Mouthwash Plus Sucralfate (Drug)
Benzydamine HCl
干预措施: 0.15% Benzydamine HCl (Drug)
结局指标
主要结局
The severity of patient-reported symptoms of mucositis as determined by the change in Oral Mucositis Weekly Questionnaire - Head and Neck Cancer (OMWQ-HN) score from baseline to 6 weeks.
时间窗: Baseline to 6 weeks after the initiation of radiotherapy.
次要结局
- The severity of patient-reported symptoms of mucositis throughout the course radiotherapy as determined by the area under the curve for mean change in OMWQ-HN scores from baseline.(Baseline to 10 weeks after initiating radiotherapy.)
- Incidence of WHO Grade 3 or 4 oral mucositis after 4 weeks of radiotherapy.(4 weeks after initiating radiotherapy)