Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis

Bitop

Status

Completed

Conditions

Oral Mucositis Due to Radiation

Treatments

Drug: Ectoin Mouth Wash

Drug: Supersaturated solution of calcium and phosphate ions

Study type

Interventional

Funder types

Industry

Identifiers

NCT03932292

btph-002-2018-EML03

Details and patient eligibility

About

This prospective non-interventional comparator study is to collect data on the clinical effectiveness and compliance of Ectoin® Mouth Wash solution (EML03) and to proof superiority to a well-established medical device on the market in the prevention of radiation-induced mucositis. The study doesn´t intervene with routine treatment strategy.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Individuals regardless of gender older than 18 years
Patients diagnosed with squamous cell carcinomas [SCCHN] without metastases of other nonhead and nonneck tumors
Patients receiving radiotherapy with a Karnofsky performance index >70%
Absence of any sign of oral mucositis at baseline (visit 1)
A definitive or postoperative treatment
Radiation therapy dosage: Limitation dose rate of 60-70 Gy
Radiotherapy of 6-7 weeks duration

Exclusion criteria

Subjects younger than 18 years
Hypersensitivity to Ectoin® or any of the other ingredients of the mouth wash
Pregnancy or breastfeeding women
Any disease that can, in the opinion of the treating physician, affect the outcome of the observational trial
Patients who had a history of previous radiotherapy in head-neck region or chemotherapy
Massive alcoholic anamnesis
Massive smoker >20 cigarettes per day at present