Back to resultsEctoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis
Primary Purpose
Oral Mucositis Due to Radiation
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Ectoin Mouth Wash
Supersaturated solution of calcium and phosphate ions
Sponsored by
About this trial
This is an interventional other trial for Oral Mucositis Due to Radiation focused on measuring Ectoin, Oral mucositis, Radiotherapy, Medical Device, Non interventional study, Mouth Wash, §23b Medical Device Act
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
Sites / Locations
- Department of Radiotherapy, National Institute of Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ectoin Mouth Wash
Supersaturated solution of calcium and phosphate ions
Arm Description
30 patients obtaining EML03 treatment
20 patients taking standard treatment (calcium phosphate mouth wash)
Outcomes
Primary Outcome Measures
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
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).
Secondary Outcome Measures
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.
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03932292
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
November 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bitop AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis Due to Radiation
Keywords
Ectoin, Oral mucositis, Radiotherapy, Medical Device, Non interventional study, Mouth Wash, §23b Medical Device Act
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ectoin Mouth Wash
Arm Type
Active Comparator
Arm Description
30 patients obtaining EML03 treatment
Arm Title
Supersaturated solution of calcium and phosphate ions
Arm Type
Active Comparator
Arm Description
20 patients taking standard treatment (calcium phosphate mouth wash)
Intervention Type
Drug
Intervention Name(s)
Ectoin Mouth Wash
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Supersaturated solution of calcium and phosphate ions
Intervention Description
According to medical prescription of the instruction for use under consideration (4 times a day).
Primary Outcome Measure Information:
Title
Change in degree of mucositis (according to WHO classification of mucositis grade) documented by the physician
Description
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
Time Frame
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)
Title
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
Description
Mucositis symptoms will be measured by using a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms).
Time Frame
day 0, day 14, day 26, day 42, Visit 5 (28 days after the last RT)
Secondary Outcome Measure Information:
Title
Number of patients with treatment-related adverse events will be assessed by using the Suspect Adverse Reaction Report Form (CIOMS Form I)
Description
All occuring adverse events/serious adverse events will be documented during the entire study period.
Time Frame
within 28 days after starting radiotherapy
Title
Changes in Karnofsky status over time by using the Karnofsky Performance Scale (KPS)
Description
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).
Time Frame
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)
Title
Tolerability assessment by using a subsequent patient questionnaire
Description
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.
Time Frame
day 28
Title
Satisfaction assessed by a subsequent patient questionnaire
Description
The following score system will be used to quantify these evaluation: "yes" 2; "maybe" = 1; and "no" = 0.
Time Frame
day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Bilstein, PhD
Organizational Affiliation
Bitop AG
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Radiotherapy, National Institute of Oncology
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis
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