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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ectoin Mouth Wash | Active Comparator | 30 patients obtaining EML03 treatment |
|
| Supersaturated solution of calcium and phosphate ions | Active Comparator | 20 patients taking standard treatment (calcium phosphate mouth wash) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ectoin Mouth Wash | Drug | 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) |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Bilstein, PhD | Bitop AG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiotherapy, National Institute of Oncology | Budapest | 1122 | Hungary |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Supersaturated solution of calcium and phosphate ions | Drug | According to medical prescription of the instruction for use under consideration (4 times a day). |
|
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 |