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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

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

Clinicaltrials.gov identifier NCT03932292

Recruitment Status Completed

First Posted April 30, 2019

Last update posted November 6, 2019

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.

  • Condition or Disease:Oral Mucositis Due to Radiation
  • Intervention/Treatment: Drug: Ectoin Mouth Wash
    Drug: Supersaturated solution of calcium and phosphate ions
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 52 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • 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
  • Actual Study Start Date: December 2018
  • Actual Primary Completion Date: October 2019
  • Actual Study Completion Date: November 2019
Arms and interventions
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).
Outcome Measures
  • Primary Outcome Measures: 1. 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
  • 2. 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).
  • Secondary Outcome Measures: 1. 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.
  • 2. 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).
  • 3. 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.
  • 4. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

Hungary
Department of Radiotherapy, National Institute of Oncology
Budapest

Sponsors and Collaborators

Bitop AG

Investigators

Study Chair: Andreas Bilstein, PhD Bitop AG

More Information
  • Responsible Party: Bitop AG
  • ClinicalTrials.gov Identifier: NCT03932292 History of Changes
  • Other Study ID Numbers: btph-002-2018-EML03
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: November 6, 2019
  • Last Verified: November 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bitop AG: Ectoin
    Oral mucositis
    Radiotherapy
    Medical Device
    Non interventional study
    Mouth Wash
    §23b Medical Device Act
  • Additional relevant MeSH terms: Mucositis Stomatitis