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

Completed

• Conditions: Mucositis

• Registration Number: NCT02816515
• Lead Sponsor: Bitop AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Primary Completion: 2017-10-24
• Study Completion: 2017-10-24
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in severity of oral mucositis as assessed by a visual examination and asking the patient about pain and discomfort	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.	day 21
Change in evaluation of pain on swallowing by using a patient-reported oral mucositis experience questionaire	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	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	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	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	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

National Koranyi Institute of TB and Pulmonology; 🇭🇺 Budapest, Hungary

Department of Oncological Internal Medicine and Clinical Pharmacology "C", National Institute of Oncology Hungary; 🇭🇺 Budapest, Hungary

National Institute of Oncology, Department of Radiotherapy 7-9 Ráth György u.; 🇭🇺 Budapest, Hungary