Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis

Study Overview
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Brief Summary
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This is a 3-week, non-interventional, observational study of patients undergoing chemotherapy (sutent) designed as a three-arm parallel study. In this study, the efficacy of Ectoin containing mouthwash given prophylactically for the prevention of mucositis in patients before radio- and/or chemotherapy; as well as during radio- and/or chemotherapy for patients with mucositis compared to standard treatment should be investigated. The study doesn't intervene with routine treatment strategy.

Official Title
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Non Interventional Clinical Investigation of Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis

Conditions
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Mucositis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving radio- and/or chemotherapy (sutent) and suffering from mucositis Female or male individuals ≥ 18 years Exclusion Criteria: Male or female under 18 years Any disease that can, in the opinion of the treating physician, affect the outcome of the study Patients with known intolerance to one of the substances used Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ectoin® mouth wash<br>The treatment will be started on the first day of radio- and/or chemotherapy, before development of mucositis | |
| Ectoin mouth wash<br>The treatment will be started after oral mucositis development in patients receiving radio- and/or chemotherapy | |
| Supersaturated electrolyte mouth rinse<br>The treatment will be started after oral mucositis development in patients receiving radio and/or chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of oral mucositis as assessed by a visual examination and asking the patient about pain and discomfort | A trained clinical member of the team scores the degree of oral mucositis, in accordance to the World Health Organization (WHO) mucositis scale 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 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days) | 
| Tolerability assessment of Ectoin Mouth Wash by using a subsequent patient questionnaire in the prevention and suppression of the severity of oral mucositis induced by radio- and/or chemotherapy. |  | day 21 | 
| Change in evaluation of pain on swallowing by using a patient-reported oral mucositis experience questionaire | A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom pain on swallowing over time on a 4-category scale ranging from 1 (none) to 4 (severe). | Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days) | 
| Change in evaluation of dry mucosa | A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom dry mucosa over time on a 4-category scale ranging from 1 (none) to 4 (severe). | Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days) | 
| Change in decreased saliva release | A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom decreased saliva release over time on a 4-category scale ranging from 1 (none) to 4 (severe). | Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days) | 
| Change in Irritation of mucosa | A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom irritation of mucosa over time on a 4-category scale ranging from 1 (none) to 4 (severe). | Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days) | 
| Change in swelling | A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom swelling over time on a 4-category scale ranging from 1 (none) to 4 (severe). | Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by the Suspect Adverse Reaction Report Form (CIOMS Form I). |  | within 21 days after starting chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non interventional study, Ectoin, Mouth wash, Mucositis, Chemotherapy, Radiotherapy