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NCT Number: NCT03932292

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.

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Key information

Conditions

Oral Mucositis Due to Radiation Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiotherapy, National Institute of Oncology

Budapest, 1122, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ectoin Mouth Wash

Drug

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 ions

Drug

According to medical prescription of the instruction for use under consideration (4 times a day).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2019
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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