Oral Mucositis Due to RadiationNCT03932292
Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis
A study testing Ectoin Mouth Wash and Supersaturated solution of calcium and phosphate ions in people with Oral Mucositis Due to Radiation, run by Bitop AG at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis Due to Radiation
- What is being tested?
- Ectoin Mouth Wash and Supersaturated solution of calcium and phosphate ions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteHungary
- Study dates
- 18 Dec 2018to 5 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Radiotherapy, National Institute of Oncology
Budapest, 1122
About this study
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
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.
- Conditions
- Oral Mucositis Due to Radiation
- Being tested
- Ectoin Mouth Wash, Supersaturated solution of calcium and phosphate ions
- Keywords
- Ectoin, Oral mucositis, Radiotherapy, Medical Device, Non interventional study, Mouth Wash, §23b Medical Device Act
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ectoin Mouth WashDrug
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 ionsDrug
According to medical prescription of the instruction for use under consideration (4 times a day).
| Study group | Role | What they receive |
|---|---|---|
| Ectoin Mouth Wash | Active comparator | 30 patients obtaining EML03 treatment Receives: Drug: Ectoin Mouth Wash |
| Supersaturated solution of calcium and phosphate ions | Active comparator | 20 patients taking standard treatment (calcium phosphate mouth wash) Receives: Drug: Supersaturated solution of calcium and phosphate ions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: day 0, day 14, day 26, day 42, Visit 5 (28 days after the last RT)
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start18 Dec 2018
- Primary completion30 Oct 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucositis Due to RadiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Bilstein, PhD, Study chair, Bitop AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932292
- Sponsor's protocol ID
- btph-002-2018-EML03
- Status last verified
- Nov 2019
- First submitted
- 17 Apr 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03932292
- Acronym / sponsor ID
- btph-002-2018-EML03
- Conditions
- Oral Mucositis Due to Radiation
- Keywords
- Ectoin, Oral mucositis, Radiotherapy, Medical Device, Non interventional study, Mouth Wash, §23b Medical Device Act
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ectoin Mouth Wash | Active comparator | Drug: Ectoin Mouth Wash30 patients obtaining EML03 treatment |
| Supersaturated solution of calcium and phosphate ions | Active comparator | Drug: Supersaturated solution of calcium and phosphate ions20 patients taking standard treatment (calcium phosphate mouth wash) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ectoin Mouth WashAccording 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) | Drug | Ectoin Mouth Wash |
| Supersaturated solution of calcium and phosphate ionsAccording to medical prescription of the instruction for use under consideration (4 times a day). | Drug | Supersaturated solution of calcium and phosphate ions |
Primary outcome
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
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).
4 secondary outcomes
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
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)
Tolerability assessment by using a subsequent patient questionnaire
Time frame: day 28
Satisfaction assessed by a subsequent patient questionnaire
Time frame: day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
Related trials for Oral Mucositis Due to Radiation
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Not yet recruiting
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation
Active, not recruitingObservational study
Multicentre Real-life Data Collection Study With CareMin650™ in the Prevention and Treatment of Oral Mucositis and Radio- and/or Chemo-induced Dermatitis
Oral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy
Not yet recruitingPhase 2
Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis
Oral Mucositis (Ulcerative) Due to Radiation
Not yet recruiting
A Sequential Cohort Study Exploring GELCLAIR in the Management of Oral Mucositis in Patients Receiving Radical Radiation for Head and Neck Cancer
Oral Mucositis Due to Radiation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Bilstein, PhD study chair
Bitop AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ectoin Mouth Wash and Supersaturated solution of calcium and phosphate ions in people with Oral Mucositis Due to Radiation, run by Bitop AG at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.