Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis
- Conditions
- Oral Mucositis Due to Radiation
- Interventions
- Drug: Ectoin Mouth Wash
- Registration Number
- NCT03932292
- Lead Sponsor
- Bitop AG
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ectoin Mouth Wash Ectoin Mouth Wash 30 patients obtaining EML03 treatment Supersaturated solution of calcium and phosphate ions Supersaturated solution of calcium and phosphate ions 20 patients taking standard treatment (calcium phosphate mouth wash)
- Primary Outcome Measures
Name Time Method Change in degree of mucositis (according to WHO classification of mucositis grade) documented by the physician 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 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).
- Secondary Outcome Measures
Name Time Method 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 All occuring adverse events/serious adverse events will be documented during the entire study period.
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) The KPS index allows patients to be classified as to their functional impairment and describes a patient's functional status as a comprehensive 11-point scale correlating to percentage values ranging from 100% (no symptoms) to 0% (death).
Tolerability assessment by using a subsequent patient questionnaire day 28 The following score system will be used to quantify these evaluation: "very good" = 4; "good" =3; "neither good nor bad" = 2; "bad" = 1 and "very bad" = 0.
Satisfaction assessed by a subsequent patient questionnaire day 28 The following score system will be used to quantify these evaluation: "yes" 2; "maybe" = 1; and "no" = 0.
Trial Locations
- Locations (1)
Department of Radiotherapy, National Institute of Oncology
🇭🇺Budapest, Hungary