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

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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

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

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

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.

* 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

Original Estimated Enrollment

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

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

Current Responsible Party

Bitop AG

Original Responsible Party

Same as current

Current Study Sponsor

Bitop AG

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Principal Investigator:

Lajos Géczi, PhD

National Institute of TB and Pulmonology

PRS Account

Bitop AG

Verification Date

January 2018

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