Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-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

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2019-11-05

Brief Summary

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This prospective non-interventional comparator study is to collect data on the clinical effectiveness and compliance of Ectoin® Mouth Wash solution (EML03) and to proof superiority to a well-established medical device on the market in the prevention of radiation-induced mucositis. The study doesn´t intervene with routine treatment strategy.

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Detailed Description

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Conditions

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Oral Mucositis Due to Radiation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ectoin Mouth Wash

30 patients obtaining EML03 treatment

Group Type ACTIVE_COMPARATOR

Ectoin Mouth Wash

Intervention Type DRUG

According to medical prescription of the instruction for use under consideration (at least 4x1 ampoule (5ml) daily, rinsed in the mouth for at least 30 seconds)

Supersaturated solution of calcium and phosphate ions

20 patients taking standard treatment (calcium phosphate mouth wash)

Group Type ACTIVE_COMPARATOR

Supersaturated solution of calcium and phosphate ions

Intervention Type DRUG

According to medical prescription of the instruction for use under consideration (4 times a day).

Interventions

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Ectoin Mouth Wash

According to medical prescription of the instruction for use under consideration (at least 4x1 ampoule (5ml) daily, rinsed in the mouth for at least 30 seconds)

Intervention Type DRUG

Supersaturated solution of calcium and phosphate ions

According to medical prescription of the instruction for use under consideration (4 times a day).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Individuals regardless of gender older than 18 years
* Patients diagnosed with squamous cell carcinomas \[SCCHN\] without metastases of other nonhead and nonneck tumors
* Patients receiving radiotherapy with a Karnofsky performance index \>70%
* Absence of any sign of oral mucositis at baseline (visit 1)
* A definitive or postoperative treatment
* Radiation therapy dosage: Limitation dose rate of 60-70 Gy
* Radiotherapy of 6-7 weeks duration

Exclusion Criteria

* Subjects younger than 18 years
* Hypersensitivity to Ectoin® or any of the other ingredients of the mouth wash
* Pregnancy or breastfeeding women
* Any disease that can, in the opinion of the treating physician, affect the outcome of the observational trial
* Patients who had a history of previous radiotherapy in head-neck region or chemotherapy
* Massive alcoholic anamnesis
* Massive smoker \>20 cigarettes per day at present

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No