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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02816515
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bitop AG

Tracking Information
First Submitted Date June 20, 2016
First Posted Date June 28, 2016
Last Update Posted Date January 18, 2018
Study Start Date January 2016
Actual Primary Completion Date October 24, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2017)
  • 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
  • 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 ]
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
Original Primary Outcome Measures
 (submitted: June 24, 2016)
  • 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
  • To evaluate the tolerability, efficacy, and safety of Ectoin Mouth Wash by using a subsequent patient questionnaire in the prevention and suppression of the severity of oral mucositis induced by chemotherapy. [ Time Frame: day 21 ]
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
Change History
Current Secondary Outcome Measures
 (submitted: June 24, 2016)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis
Official Title Non Interventional Clinical Investigation of Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects with radio- and/or chemotherapy-induced mucositis
Condition Mucositis
Intervention Not Provided
Study Groups/Cohorts
  • Ectoin® mouth wash
    The treatment will be started on the first day of radio- and/or chemotherapy, before development of mucositis
  • Ectoin mouth wash
    The treatment will be started after oral mucositis development in patients receiving radio- and/or chemotherapy
  • Supersaturated electrolyte mouth rinse
    The treatment will be started after oral mucositis development in patients receiving radio and/or chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 17, 2018)
46
Original Estimated Enrollment
 (submitted: June 24, 2016)
80
Actual Study Completion Date October 24, 2017
Actual Primary Completion Date October 24, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT02816515
Other Study ID Numbers 2016/EML/NIS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bitop AG
Study Sponsor Bitop AG
Collaborators Not Provided
Investigators
Principal Investigator: Lajos Géczi, PhD National Institute of TB and Pulmonology
PRS Account Bitop AG
Verification Date January 2018