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

November 5, 2019 updated by: Bitop AG

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in degree of mucositis (according to WHO classification of mucositis grade) documented by the physician
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)
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
Time Frame: day 0, day 14, day 26, day 42, Visit 5 (28 days after the last RT)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Time Frame: within 28 days after starting radiotherapy
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)
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)
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
Time Frame: day 28
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
Time Frame: day 28
The following score system will be used to quantify these evaluation: "yes" 2; "maybe" = 1; and "no" = 0.
day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bitop AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Andreas Bilstein, PhD, bitop AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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