Non Interventional Clinical Investigation of Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mucositis
- Sponsor
- Bitop AG
- Enrollment
- 46
- Locations
- 3
- Primary Endpoint
- Change in severity of oral mucositis as assessed by a visual examination and asking the patient about pain and discomfort
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in severity of oral mucositis as assessed by a visual examination and asking the patient about pain and discomfort
Time Frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)
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
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.
Time Frame: day 21
Change in evaluation of pain on swallowing by using a patient-reported oral mucositis experience questionaire
Time Frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)
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).
Change in evaluation of dry mucosa
Time Frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)
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).
Change in decreased saliva release
Time Frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)
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).
Change in Irritation of mucosa
Time Frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)
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).
Change in swelling
Time Frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)
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).
Secondary Outcomes
- 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)