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

Oral Mucositis Due to Radiation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03932292
• Other study ID #: btph-002-2018-EML03
• Status: Completed
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: November 5, 2019

Study information

• Verified date: November 2019
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 5, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis Due to Radiation
• Stomatitis

Intervention

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)
• Supersaturated solution of calcium and phosphate ions
According to medical prescription of the instruction for use under consideration (4 times a day).

Locations

Country	Name	City	State
Hungary	Department of Radiotherapy, National Institute of Oncology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in degree of mucositis (according to WHO classification of mucositis grade) documented by the physician	The degree of oral mucositis will be assessed as follow: grade 0, no signs or symptoms; grade 1, oral soreness and erythema; grade 2, oral erythema, ulcers and solid diet tolerated; grade 3, oral ulcers and liquid diet only; grade 4, oral alimentation impossible	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)
Primary	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	Mucositis symptoms will be measured by using a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms).	day 0, day 14, day 26, day 42, Visit 5 (28 days after the last RT)
Secondary	Number of patients with treatment-related adverse events will be assessed by using the Suspect Adverse Reaction Report Form (CIOMS Form I)	All occuring adverse events/serious adverse events will be documented during the entire study period.	within 28 days after starting radiotherapy
Secondary	Changes in Karnofsky status over time by using the Karnofsky Performance Scale (KPS)	The KPS index allows patients to be classified as to their functional impairment and describes a patient's functional status as a comprehensive 11-point scale correlating to percentage values ranging from 100% (no symptoms) to 0% (death).	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)
Secondary	Tolerability assessment by using a subsequent patient questionnaire	The following score system will be used to quantify these evaluation: "very good" = 4; "good" =3; "neither good nor bad" = 2; "bad" = 1 and "very bad" = 0.	day 28
Secondary	Satisfaction assessed by a subsequent patient questionnaire	The following score system will be used to quantify these evaluation: "yes" 2; "maybe" = 1; and "no" = 0.	day 28