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

NCT03932292 | Completed

• 1 other identifier: btph-002-2018-EML03
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Mucositis Due to Radiation

Keywords

Ectoin; Oral mucositis; Radiotherapy; Medical Device; Non interventional study; Mouth Wash; §23b Medical Device Act

Outcome Measures

Primary Outcomes (2)

• Change in degree of mucositis (according to WHO classification of mucositis grade) documented by the physician

  The degree of oral mucositis will be assessed 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

  Visit 1 (day 0), Visit 2 (after 14 days), Visit 3 (after 28 days), Visit 4 (after 42 days), Visit 5 (28 days after the last RT)

• Change in mucositis symptoms dry mucosa, irritation of mucosa, coated tongue, unpleasant breath, decreased saliva release, pain, swelling, ulcer, difficulty to speak and difficulty to eat and dring by using a Numeric Rating Scale

  Mucositis symptoms will be measured by using a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms).

  day 0, day 14, day 26, day 42, Visit 5 (28 days after the last RT)

Secondary Outcomes (4)

• Number of patients with treatment-related adverse events will be assessed by using the Suspect Adverse Reaction Report Form (CIOMS Form I)

  within 28 days after starting radiotherapy

• Changes in Karnofsky status over time by using the Karnofsky Performance Scale (KPS)

  Visit 1 (day 0), Visit 2 (after 14 days), Visit 3 (after 28 days), Visit 4 (after 42 days), Visit 5 (after 28 days after the last RT)

• Tolerability assessment by using a subsequent patient questionnaire

  day 28

• Satisfaction assessed by a subsequent patient questionnaire

  day 28

Study Arms (2)

Ectoin Mouth Wash

ACTIVE COMPARATOR

30 patients obtaining EML03 treatment

Drug: Ectoin Mouth Wash

Supersaturated solution of calcium and phosphate ions

ACTIVE COMPARATOR

20 patients taking standard treatment (calcium phosphate mouth wash)

Drug: Supersaturated solution of calcium and phosphate ions

Interventions

Ectoin Mouth Wash 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)

Ectoin Mouth Wash

Supersaturated solution of calcium and phosphate ions DRUG

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

Supersaturated solution of calcium and phosphate ions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (1)

Department of Radiotherapy, National Institute of Oncology

Budapest, 1122, Hungary

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andreas Bilstein, PhD

  Bitop AG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 30, 2019
• Study Start: December 18, 2018
• Primary Completion: October 30, 2019
• Study Completion: November 5, 2019
• Last Updated: November 6, 2019

Record last verified: 2019-11

Locations

HU (1)