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

• Status: Completed
• Trial end date: 2019-11-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bitop AG
• Treatments: Calcium; Calcium, Dietary

Criteria

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