Feasibility and Safety of CareMin650 in Patients at Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis

NACompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

July 4, 2019

Primary Completion Date

December 17, 2020

Study Completion Date

December 17, 2020

Conditions
Oral Mucositis Due to RadiationRadiation Dermatitis
Interventions
DEVICE

Photobiomodulation using CareMin650 at 6 Joules (curative intent)

"CareMin650 is a photobiomodulation device which consists of a Lightbox and a light applicator to deliver red light with wavelength of 650 nm and irradiance between 10 and 50 mW/cm² to skin or mucosa.~For curative treatment, the dose to be delivered has been set at 6J/cm2. If the lesions of patients included in a curative cohort are resolved before the end of the radiotherapy period, the treatment will be applied with a preventive aim and the dose will decrease from 6 to 3J/cm2."

DEVICE

Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)

"CareMin650 is a photobiomodulation device which consists of a Lightbox and a light applicator to deliver red light with wavelength of 650 nm and irradiance between 10 and 50 mW/cm² to skin or mucosa.~For prophylactic treatment, the dose to be delivered has been set at 3J/cm2. If oral mucositis or radiodermatitis occurs in a patient included in a prophylactic cohort, the lesions will be treated with a curative intent and the dose will increase from 3 to 6J/cm2."

Trial Locations (5)

42270

Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez

59000

Centre Oscar Lambret, Lille

75248

Institut Curie, Paris

92309

Institut de radiothérapie et radiochirurgie Hartmann, Levallois-Perret

06000

Centre de Haute Energie, Nice

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Qualissima

OTHER

lead

NeoMedLight

INDUSTRY

NCT03988556 - Feasibility and Safety of CareMin650 in Patients at Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis | Biotech Hunter | Biotech Hunter