Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT03932292
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03932292
Study Brief:
Protocol Section:
NCT03932292