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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-10-24

Brief Summary

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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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Detailed Description

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Conditions

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Mucositis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ectoin® mouth wash

The treatment will be started on the first day of radio- and/or chemotherapy, before development of mucositis

No interventions assigned to this group

Ectoin mouth wash

The treatment will be started after oral mucositis development in patients receiving radio- and/or chemotherapy

No interventions assigned to this group

Supersaturated electrolyte mouth rinse

The treatment will be started after oral mucositis development in patients receiving radio and/or chemotherapy

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No