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NCT Number: NCT02816515

Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis

This is a 3-week, non-interventional, observational study of patients undergoing chemotherapy (sutent) designed as a three-arm parallel study. In this study, the efficacy of Ectoin containing mouthwash given prophylactically for the prevention of mucositis in patients before radio- and/or chemotherapy; as well as during radio- and/or chemotherapy for patients with mucositis compared to standard treatment should be investigated. The study doesn't intervene with routine treatment strategy.

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Key information

Conditions

Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncological Internal Medicine and Clinical Pharmacology "C", National Institute of Oncology Hungary, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients receiving radio- and/or chemotherapy (sutent) and suffering from mucositis
  • Female or male individuals ≥ 18 years

Exclusion criteria

  • Male or female under 18 years
  • Any disease that can, in the opinion of the treating physician, affect the outcome of the study
  • Patients with known intolerance to one of the substances used
  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Change in severity of oral mucositis as assessed by a visual examination and asking the patient about pain and discomfort

    Time frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)

    A trained clinical member of the team scores the degree of oral mucositis, in accordance to the World Health Organization (WHO) mucositis scale 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. Tolerability assessment of Ectoin Mouth Wash by using a subsequent patient questionnaire in the prevention and suppression of the severity of oral mucositis induced by radio- and/or chemotherapy.

    Time frame: day 21

  3. Change in evaluation of pain on swallowing by using a patient-reported oral mucositis experience questionaire

    Time frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)

    A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom pain on swallowing over time on a 4-category scale ranging from 1 (none) to 4 (severe).

  4. Change in evaluation of dry mucosa

    Time frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)

    A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom dry mucosa over time on a 4-category scale ranging from 1 (none) to 4 (severe).

  5. Change in decreased saliva release

    Time frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)

    A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom decreased saliva release over time on a 4-category scale ranging from 1 (none) to 4 (severe).

  6. Change in Irritation of mucosa

    Time frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)

    A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom irritation of mucosa over time on a 4-category scale ranging from 1 (none) to 4 (severe).

  7. Change in swelling

    Time frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)

    A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom swelling over time on a 4-category scale ranging from 1 (none) to 4 (severe).

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by the Suspect Adverse Reaction Report Form (CIOMS Form I).

    Time frame: within 21 days after starting chemotherapy

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study title

Non Interventional Clinical Investigation of Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2016
Registry last updated
Jan 18, 2018

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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