Clinical trial NCT03932292: Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis
Official title: Prospective Comparator Study to Evaluate the Efficacy and Tolerability of Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis Due to Radiation
Keywords: Ectoin
Oral mucositis
Radiotherapy
Medical Device
Non interventional study
Mouth Wash
§23b Medical Device Act
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2019-04-30
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


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

Primary outcomes:
measure: Change in degree of mucositis (according to WHO classification of mucositis grade) documented by the physician
timeFrame: Visit 1 (day 0), Visit 2 (after 14 days), Visit 3 (after 28 days), Visit 4 (after 42 days), Visit 5 (28 days after the last RT)
measure: Change in mucositis symptoms dry mucosa, irritation of mucosa, coated tongue, unpleasant breath, decreased saliva release, pain, swelling, ulcer, difficulty to speak and difficulty to eat and dring by using a Numeric Rating Scale
timeFrame: day 0, day 14, day 26, day 42, Visit 5 (28 days after the last RT)
Secondary outcomes:
measure: Number of patients with treatment-related adverse events will be assessed by using the Suspect Adverse Reaction Report Form (CIOMS Form I)
timeFrame: within 28 days after starting radiotherapy
measure: Changes in Karnofsky status over time by using the Karnofsky Performance Scale (KPS)
timeFrame: Visit 1 (day 0), Visit 2 (after 14 days), Visit 3 (after 28 days), Visit 4 (after 42 days), Visit 5 (after 28 days after the last RT)
measure: Tolerability assessment by using a subsequent patient questionnaire
timeFrame: day 28
measure: Satisfaction assessed by a subsequent patient questionnaire
timeFrame: day 28
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Department of Radiotherapy, National Institute of Oncology
Study officials:
affiliation: Bitop AG
name: Andreas Bilstein, PhD
role: STUDY_CHAIR
References: