Prospective Comparator Study to Evaluate the Efficacy and Tolerability of Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in degree of mucositis (according to WHO classification of mucositis grade) documented by the physician
研究概览
简要总结
This prospective non-interventional comparator study is to collect data on the clinical effectiveness and compliance of Ectoin® Mouth Wash solution (EML03) and to proof superiority to a well-established medical device on the market in the prevention of radiation-induced mucositis. The study doesn´t intervene with routine treatment strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Individuals regardless of gender older than 18 years
- •Patients diagnosed with squamous cell carcinomas [SCCHN] without metastases of other nonhead and nonneck tumors
- •Patients receiving radiotherapy with a Karnofsky performance index >70%
- •Absence of any sign of oral mucositis at baseline (visit 1)
- •A definitive or postoperative treatment
- •Radiation therapy dosage: Limitation dose rate of 60-70 Gy
- •Radiotherapy of 6-7 weeks duration
排除标准
- •Subjects younger than 18 years
- •Hypersensitivity to Ectoin® or any of the other ingredients of the mouth wash
- •Pregnancy or breastfeeding women
- •Any disease that can, in the opinion of the treating physician, affect the outcome of the observational trial
- •Patients who had a history of previous radiotherapy in head-neck region or chemotherapy
- •Massive alcoholic anamnesis
- •Massive smoker >20 cigarettes per day at present
研究组 & 干预措施
Ectoin Mouth Wash
30 patients obtaining EML03 treatment
干预措施: Ectoin Mouth Wash (Drug)
Supersaturated solution of calcium and phosphate ions
20 patients taking standard treatment (calcium phosphate mouth wash)
干预措施: Supersaturated solution of calcium and phosphate ions (Drug)
结局指标
主要结局
Change in degree of mucositis (according to WHO classification of mucositis grade) documented by the physician
时间窗: Visit 1 (day 0), Visit 2 (after 14 days), Visit 3 (after 28 days), Visit 4 (after 42 days), Visit 5 (28 days after the last RT)
The degree of oral mucositis will be assessed as follow: grade 0, no signs or symptoms; grade 1, oral soreness and erythema; grade 2, oral erythema, ulcers and solid diet tolerated; grade 3, oral ulcers and liquid diet only; grade 4, oral alimentation impossible
Change in mucositis symptoms dry mucosa, irritation of mucosa, coated tongue, unpleasant breath, decreased saliva release, pain, swelling, ulcer, difficulty to speak and difficulty to eat and dring by using a Numeric Rating Scale
时间窗: day 0, day 14, day 26, day 42, Visit 5 (28 days after the last RT)
Mucositis symptoms will be measured by using a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms).
次要结局
- Number of patients with treatment-related adverse events will be assessed by using the Suspect Adverse Reaction Report Form (CIOMS Form I)(within 28 days after starting radiotherapy)
- Changes in Karnofsky status over time by using the Karnofsky Performance Scale (KPS)(Visit 1 (day 0), Visit 2 (after 14 days), Visit 3 (after 28 days), Visit 4 (after 42 days), Visit 5 (after 28 days after the last RT))
- Tolerability assessment by using a subsequent patient questionnaire(day 28)
- Satisfaction assessed by a subsequent patient questionnaire(day 28)