The aim of this feasibility, prospective, single-center trial is to compare an intra-oral Photobiomodulation (PBM) via the Caremin650TM device (NeoMedLight) and a transcutaneous PBM via the ATP 38® device (Swiss Bio Innov) in patients treated with radiotherapy or chemoradiotherapy for cancer of the oropharynx or oral cavity. PBM session will be carried out first at the rate of two sessions per week for preventive purposes, and then, in case of occurence of grade 1 mucositis, three sessions per week with curative purpose.
Oral mucositis (OM) is defined as damage to the mucosa of the oral cavity; it can be due to chemotherapy or radiotherapy. The incidence of OM is 59 to 100% according to studies in patients with oral cavity or oropharyngeal cancer receiving radiotherapy. Clinically, OM is characterized by erythematous changes in the mucosa, which can progress to oral ulcerations. It can significantly alter the quality of life, the ability to eat, cause weight loss in patients and interfere with the proper realization of anti-tumoral treatment. Additionally, OM may increase the risk of bacteremia and sepsis in immunocompromised patients. So far, effective management strategies for OM and associated pain are still insufficient. A wide variety of topical and oral agents are available, but effectiveness is still lacking. Photobiomodulation (PBM) therapy involves the application of visible or infrared light produced by laser diodes or light-emitting diodes (LEDs) to stimulate wound healing, reduce inflammation, and decrease pain. PBM can be performed in two main ways: intraoral and transcutaneous. Intraoral PBM involves applying red or near-infrared light directly in contact with the oral mucosa, while transcutaneous PBM involves the application of infrared radiation to the skin. Both techniques have shown their effectiveness. Numerous trials have evaluated the impact of PBM in radiomucositis but its use in clinical practice is to date not widespread and heterogeneous.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
use of CareMin650TM lightbox(NeoMedLight) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose
use of ATP38® phototherapy device (Swiss Bio Inov Europe) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose
Institut de cancérologie Strasbourg Europe
Strasbourg, France
Cumulative incidence of oral mucositis (grade ≥ 2) in both group (intraoral and transcutaneous PBM)
Oral mucositis will be graded according to NCI-CTCAE V5.0 criteria
Time frame: Until OM resolution, up to 12 weeks
Radiotherapy treatment interruption in both group (intraoral and transcutaneous PBM)
Number of cancelled radiotherapy sessions in comparison to initial treatment plan
Time frame: Until OM resolution, up to 12 weeks
Duration of oral mucositis in both group (intraoral and transcutaneous PBM)
Number of days
Time frame: Until OM resolution, up to 12 weeks
Number of hospitals stays in both group (intraoral and transcutaneous PBM)
Number of unscheduled hospitalizations
Time frame: Until OM resolution, up to 12 weeks
Number of introductions of parenteral nutrition in both group (intraoral and transcutaneous PBM)
Number of days from radiotherapy initiation until artificial nutrition introduction
Time frame: Until OM resolution, up to 12 weeks
Infection rate in both group (intraoral and transcutaneous PBM)
Infections graded according to NCI-CTCAE V5.0 criteria
Time frame: Until OM resolution, up to 12 weeks
Food intake in both group (intraoral and transcutaneous PBM)
Measured on a weekly basis with the Simple Evaluation of Food Intake (SEFI) tool
Time frame: Until OM resolution, up to 12 weeks
Pain level in both group (intraoral and transcutaneous PBM)
Measured with a visual analogic scale (VAS), graded from 0 to 10
Time frame: Until OM resolution, up to 12 weeks
Quality of life of patients in both group (intraoral and transcutaneous PBM)
Questionnaire from EORTC: QLQ-C30 with organ specific QLQ-HN35 module
Time frame: Until OM resolution, up to 12 weeks
Dry mouth rate in both group (intraoral and transcutaneous PBM)
Graded according to NCI-CTCAE V5.0 criteria
Time frame: Until OM resolution, up to 12 weeks
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