Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Comparator Study to Evaluate the Efficacy and Tolerability of Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis

Conditions
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Oral Mucositis Due to Radiation

Intervention / Treatment
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* Drug: Ectoin Mouth Wash
* Drug: Supersaturated solution of calcium and phosphate ions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ectoin Mouth Wash<br>30 patients obtaining EML03 treatment | Drug: Ectoin Mouth Wash<br>* According to medical prescription of the instruction for use under consideration (at least 4x1 ampoule (5ml) daily, rinsed in the mouth for at least 30 seconds)<br>|
| Active Comparator: Supersaturated solution of calcium and phosphate ions<br>20 patients taking standard treatment (calcium phosphate mouth wash) | Drug: Supersaturated solution of calcium and phosphate ions<br>* According to medical prescription of the instruction for use under consideration (4 times a day).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in degree of mucositis (according to WHO classification of mucositis grade) documented by the physician | 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 | 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) | 
| 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 | Mucositis symptoms will be measured by using a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms). | day 0, day 14, day 26, day 42, Visit 5 (28 days after the last RT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment-related adverse events will be assessed by using the Suspect Adverse Reaction Report Form (CIOMS Form I) | All occuring adverse events/serious adverse events will be documented during the entire study period. | within 28 days after starting radiotherapy | 
| Changes in Karnofsky status over time by using the Karnofsky Performance Scale (KPS) | 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). | 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 | 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. | day 28 | 
| Satisfaction assessed by a subsequent patient questionnaire | The following score system will be used to quantify these evaluation: yes 2; maybe = 1; and no = 0. | day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ectoin, Oral mucositis, Radiotherapy, Medical Device, Non interventional study, Mouth Wash, §23b Medical Device Act