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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ectoin® mouth wash | The treatment will be started on the first day of radio- and/or chemotherapy, before development of mucositis | ||
| Ectoin mouth wash | The treatment will be started after oral mucositis development in patients receiving radio- and/or chemotherapy | ||
| Supersaturated electrolyte mouth rinse | The treatment will be started after oral mucositis development in patients receiving radio and/or chemotherapy |
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| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with radio- and/or chemotherapy-induced mucositis
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| Name | Affiliation | Role |
|---|---|---|
| Lajos Géczi, PhD | National Institute of TB and Pulmonology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncological Internal Medicine and Clinical Pharmacology "C", National Institute of Oncology Hungary | Budapest | 1026 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32700140 | Derived | Dao VA, Bilstein A, Overhagen S, Geczi L, Barath Z, Mosges R. Effectiveness, Tolerability, and Safety of Ectoine-Containing Mouthwash Versus Those of a Calcium Phosphate Mouthwash for the Treatment of Chemotherapy-Induced Oral Mucositis: A Prospective, Active-Controlled, Non-interventional Study. Oncol Ther. 2018 Jun;6(1):59-72. doi: 10.1007/s40487-018-0060-z. Epub 2018 May 9. |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| 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) |
| National Koranyi Institute of TB and Pulmonology | Budapest | 1121 | Hungary |
| National Institute of Oncology, Department of Radiotherapy 7-9 Ráth György u. | Budapest | Hungary |
| D009057 |
| Stomatognathic Diseases |