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History of Changes for Study: NCT02816515
Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis
Latest version (submitted January 17, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 24, 2016 None (earliest Version on record)
2 June 28, 2016 Outcome Measures and Study Status
3 December 5, 2016 Study Status
4 January 17, 2017 Study Status, Contacts/Locations, Eligibility, Outcome Measures, Groups and Interventions, Conditions and Study Description
5 January 17, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02816515
Submitted Date:  June 24, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2016/EML/NIS
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2016
Overall Status: Recruiting
Study Start: January 2016
Primary Completion: October 2016 [Anticipated]
Study Completion: December 2016 [Anticipated]
First Submitted: June 20, 2016
First Submitted that
Met QC Criteria:
June 24, 2016
First Posted: June 28, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 24, 2016
Last Update Posted: June 28, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bitop AG
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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 chemotherapy; as well as during chemotherapy for patients with mucositis compared to standard treatment should be investigated. The study doesn't intervene with routine treatment strategy.
Detailed Description:
Open or close this module Conditions
Conditions: Mucositis
Keywords: Non interventional study
Ectoin
Mouth wash
Mucositis
Chemotherapy
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Only
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 80 [Anticipated]
Number of Groups/Cohorts 3
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Ectoin® mouth wash
The treatment will be started on the first day of chemotherapy, before development of mucositis
Ectoin mouth wash
The treatment will be started after oral mucositis development in patients receiving chemotherapy
Supersaturated electrolyte mouth rinse
The treatment will be started after oral mucositis development in patients receiving chemotherapy
Open or close this module Outcome Measures
Primary Outcome Measures:
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. 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 ]

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 Outcome Measures:
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 ]

Open or close this module Eligibility
Study Population: Subjects with chemotherapy-induced mucositis
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 99 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Patients receiving 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
Open or close this module Contacts/Locations
Central Contact Person: Andreas Bilstein, PhD
Telephone: +49(0)2302914400
Study Officials: Lajos Géczi, PhD
Principal Investigator
National Institute of TB and Pulmonology
Locations: Hungary
Department of Oncological Internal Medicine and Clinical Pharmacology "C", National Institute of Oncology Hungary
[Recruiting]
Budapest, Hungary, 1026
Contact:Contact: Lajos Géczi, PhD
National Koranyi Institute of TB and Pulmonology
[Recruiting]
Budapest, Hungary, 1121
Contact:Contact: Zoltán Baráth, Phd
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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