Treatment of oral mucositis using Mucopad HA
Multi-centre, Open-label, First-in-man Study With Mucopad HA Used in Adult Patients Suffered From Oral Mucositis After Radiotherapy
This study is testing a new device called Mucopad HA to see if it can help people with oral mucositis feel better after receiving radiotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Contipro Pharma a.s. Academic / other |
| Locations | 5 sites (Brno, Česká Republika and 4 other locations) |
| Trial ID | NCT06276270 on ClinicalTrials.gov |
What this trial studies
This clinical trial is an open-label, multi-centre study evaluating the safety and efficacy of a new medical device, Mucopad HA, for treating oral mucositis in patients who have undergone radiotherapy. Up to 60 patients aged 18 and older with grade I-IV oral mucositis will participate, receiving treatment for up to 10 weeks. The study aims to assess improvements in healing, measured by the WHO scale, and quality of life through the Oral Mucositis Daily Questionnaire (OMDQ).
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with oral mucositis of grade I-IV following radiotherapy.
Not a fit: Patients under 18, pregnant or lactating women, and those with severe allergies or terminal illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing outcomes and quality of life for patients suffering from oral mucositis.
How similar studies have performed: While this approach is novel, similar studies targeting oral mucositis have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brno, Česká Republika and 4 other locations
- Masarykův onkologický ústav, Klinika radiační onkologie — Brno, Česká Republika, Czechia (Recruiting)
- FN Hradec Králové Klinika onkologie a radioterapie — Hradec Králové, Česká Republika, Czechia (Recruiting)
- Fakultní nemocnice Ostrava, Klinika onkologická — Ostrava, Česká Republika, Czechia (Recruiting)
- Etická komise FN Bulovka — Praha, Česká Republika, Czechia (Recruiting)
- Fakultní Thomayerova nemocnice Onkologická klinika 1.LF UK a FTN — Praha, Česká Republika, Czechia (Recruiting)
Study contacts
- Study coordinator: Pavel Kušnierik
- Email: pavel.kusnierik@contipro.com
- Phone: +420775418823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.