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

Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816515
• Other study ID #: 2016/EML/NIS
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: January 17, 2018
• Start date: January 2016
• Est. completion date: October 24, 2017

Study information

• Verified date: January 2018
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 24, 2017
• Est. primary completion date: October 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Stomatitis

Locations

Country	Name	City	State
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	National Koranyi Institute of TB and Pulmonology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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