Clinical trial NCT06276270: Multi-centre, Open-label, First-in-man Study With Mucopad HA
Official title: Multi-centre, Open-label, First-in-man Study With Mucopad HA Used in Adult Patients Suffered From Oral Mucositis After Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Mucositis
Lead sponsor: Contipro Pharma a.s.
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resolution of mucositis symptoms since completion of radiotherapy
timeFrame: 10 weeks
Secondary outcomes:
measure: - Pain management (VAS scale)
timeFrame: 10 weeks
measure: Development of xerostomy
timeFrame: 10 weeks
measure: Subjective evaluation on scale 1-5 of the treatment by investigator/ patient
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Masarykův onkologický ústav, Klinika radiační onkologie
state: Česká Republika
city: Hradec Králové
country: Czechia
facility: FN Hradec Králové Klinika onkologie a radioterapie
state: Česká Republika
city: Ostrava
country: Czechia
facility: Fakultní nemocnice Ostrava, Klinika onkologická
state: Česká Republika
city: Praha
country: Czechia
facility: Etická komise FN Bulovka
state: Česká Republika
city: Praha
country: Czechia
facility: Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN
state: Česká Republika
Study officials:
References: