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

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 Overview

• Status: Completed
• Conditions: Oral Mucositis Due to Radiation
• Intervention / Treatment: Drug: Ectoin Mouth Wash; Drug: Supersaturated solution of calcium and phosphate ions

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1122
    • Department of Radiotherapy, National Institute of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ectoin Mouth Wash; 30 patients obtaining EML03 treatment	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)
Active Comparator: Supersaturated solution of calcium and phosphate ions; 20 patients taking standard treatment (calcium phosphate mouth wash)	Drug: Supersaturated solution of calcium and phosphate ions; According to medical prescription of the instruction for use under consideration (4 times a day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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

Collaborators and Investigators

• Sponsor: Bitop AG
• Investigators: Study Chair: Andreas Bilstein, PhD, bitop AG

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2018
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): November 5, 2019

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Radiotherapy; Oral mucositis; Medical Device; Ectoin; Non interventional study; Mouth Wash; §23b Medical Device Act
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: btph-002-2018-EML03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No