Trial | NCT03932292  Report issue

Title

Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis
Prospective Comparator Study to Evaluate the Efficacy and Tolerability of Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    52
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.
Study Started
Dec 18
2018
Primary Completion
Oct 30
2019
Study Completion
Nov 05
2019
Last Update
Nov 06
2019

Drug Ectoin Mouth Wash

According to medical prescription of the instruction for use under consideration (at least 4x1 ampoule (5ml) daily, rinsed in the mouth for at least 30 seconds)

Drug Supersaturated solution of calcium and phosphate ions

According to medical prescription of the instruction for use under consideration (4 times a day).

Ectoin Mouth Wash Active Comparator

30 patients obtaining EML03 treatment

Supersaturated solution of calcium and phosphate ions Active Comparator

20 patients taking standard treatment (calcium phosphate mouth wash)

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
No Results Posted