72
Participants
Start Date
July 4, 2019
Primary Completion Date
December 17, 2020
Study Completion Date
December 17, 2020
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."
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."
Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez
Centre Oscar Lambret, Lille
Institut Curie, Paris
Institut de radiothérapie et radiochirurgie Hartmann, Levallois-Perret
Centre de Haute Energie, Nice
Lead Sponsor
Qualissima
OTHER
NeoMedLight
INDUSTRY