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

Bitop

Status: Completed

Conditions: Mucositis

Study type: Observational

Funder types: Industry

Identifiers

NCT02816515

2016/EML/NIS

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

46 participants in 3 patient groups

Ectoin® mouth wash

Description:

The treatment will be started on the first day of radio- and/or chemotherapy, before development of mucositis

Ectoin mouth wash

Description:

The treatment will be started after oral mucositis development in patients receiving radio- and/or chemotherapy

Supersaturated electrolyte mouth rinse

Description:

The treatment will be started after oral mucositis development in patients receiving radio and/or chemotherapy