Efficacy and Safety of CareMin650 for Prevention of Oral Mucositis in HNC Patients Starting Radiotherapy

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

May 10, 2021

Primary Completion Date

March 31, 2022

Study Completion Date

June 30, 2022

Conditions
Head and Neck CancerOral Mucositis (Ulcerative) Due to RadiationRadiation Therapy Complication
Interventions
DEVICE

Photobiomodulation

"Oral pads will be applied on irradiated areas presenting a risk of radiotherapy-related OM. In addition, a derma pad will be applied on the anterior face of the neck to protect the oropharynx from OM.~The dose to be delivered, at each session and each applied area, has been set at 3 J/cm². In case a lesion appears, the dose will be increased to 6J/cm² for curative treatment.~Treatment with CareMin650 must start on the first day of radiotherapy and will be administered during the whole radiotherapy period, ideally 5 days/week, at least 3 days/week, ideally before the radiotherapy session."

Trial Locations (1)

52074

UNIKLINIK RWTH AACHEN - Klinik für Radioonkologie und Strahlentherapie, Aachen

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Monitoring Force Group

INDUSTRY

lead

NeoMedLight

INDUSTRY

NCT04699487 - Efficacy and Safety of CareMin650 for Prevention of Oral Mucositis in HNC Patients Starting Radiotherapy | Biotech Hunter | Biotech Hunter