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

• ClinicalTrials.gov Identifier: NCT02816515
• Recruitment Status: Completed
• First Posted: June 28, 2016
• Last Update Posted: January 18, 2018
• Sponsor: Bitop AG
• 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).

• 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 *: Dao VA, Bilstein A, Overhagen S, Géczi L, Baráth Z, Mösges R. Effectiveness, Tolerability, and Safety of Ectoine-Containing Mouthwash Versus Those of a Calcium Phosphate Mouthwash for the Treatment of Chemotherapy-Induced Oral Mucositis: A Prospective, Active-Controlled, Non-interventional Study. Oncol Ther. 2018 Jun;6(1):59-72. doi: 10.1007/s40487-018-0060-z. Epub 2018 May 9.

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

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