Multi-centre, Open-label, First-in-man Study With Mucopad HA

Not Applicable

Recruiting

• Conditions: Oral Mucositis
• Interventions: Device: Mucopad HA

• Registration Number: NCT06276270
• Lead Sponsor: Contipro Pharma a.s.

Brief Summary

The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results.

Detailed Description

This is an multi-centre, open-label, first-in-man prospective study.

Up to 60 patients in total will be involved in the open-label trial of new medical device - Mucopad HA. Eligible patients will be undergoing treatment with the device for up to 10 weeks, after which it is expected that there should be significant improvement in the healing process of oral mucositis after radiotherapy. It is considered as an improvement when there is a significant reduction or complete resolution of the mucositis. Mucositis will be assessed as a WHO scale.

Quality of life will be assessed by Oral Mucositis Daily Questionnaire (OMDQ) provided by FACIT. The FACIT and all related works are owned and copyrighted by, and the intellectual property of David Cella, Ph.D. Permission for use of the OMDQ questionnaire is obtained by contacting Dr. Cella at information@facit.org.

List of investigational sites is in appendix 7.

Study Timeline

• Study Start: 2023-12-12
• Status Verified: 2024-02
• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-21
• Last Update Submitted: 2024-02-21
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥ 18 years
• Oral Mucositis after radiotherapy of grade I - IV according to WHO
• Patient willing and able to provide the written consent
• Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study

Exclusion Criteria

• Age < 18 years
• Pregnant or lactating women
• Patients in terminal stage of living
• Patients with known hypersensitivity or allergy to any of the substances contained in Medical Device
• Alcohol or drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Device is administered directly onto the area affected by mucositis.	Mucopad HA	-

Primary Outcome Measures

Name	Time	Method
Resolution of mucositis symptoms since completion of radiotherapy	10 weeks	healing time

Secondary Outcome Measures

Name	Time	Method
- Pain management (VAS scale)	10 weeks	pain value 1-100
Development of xerostomy	10 weeks	xerostomy yes/no
Subjective evaluation on scale 1-5 of the treatment by investigator/ patient	10 weeks	scale 1-5

Trial Locations

Locations (5)

Masarykův onkologický ústav, Klinika radiační onkologie; 🇨🇿 Brno, Česká Republika, Czechia

FN Hradec Králové Klinika onkologie a radioterapie; 🇨🇿 Hradec Králové, Česká Republika, Czechia

Fakultní nemocnice Ostrava, Klinika onkologická; 🇨🇿 Ostrava, Česká Republika, Czechia

Etická komise FN Bulovka; 🇨🇿 Praha, Česká Republika, Czechia

Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN; 🇨🇿 Praha, Česká Republika, Czechia