Evaluation of Two Methods of Administration of Photobiomodulation in the Context of the Prevention and Treatment of Mucositis Induced by Radiotherapy, During the Treatment of Head and Neck Cancers

Head and Neck Neoplasms Clinical Trial

— RADIO-PBM  

Official title:

Pilot Observational Study of Transcutaneous and Intraoral Photobiomodulation in the Prevention and Treatment of Radiomucositis in Head and Neck Cancers Treated by Radiotherapy - RADIO-PBM Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458517
• Other study ID #: 2022-018
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2, 2024
• Est. completion date: May 2, 2026

Study information

• Verified date: June 2024
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Manon VOEGELIN
• Phone: VOEGELIN
• Email: promotion-rc[@]icans.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2, 2026
• Est. primary completion date: May 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient (18 years old and older);

• Patients with oral cavity or oropharynx cancer treated with radiotherapy or chemo-radiotherapy;

• Karnofsky Performance Status > 60%;

• Able to understand French;

• With signed informed consent;

• Affiliated to French Health Security Insurance

Exclusion Criteria:

• Allergy to polyurethanes;

• Head and Neck tumors that are localized to other sites than oral cavity or oropharynx

• Previous irradiation of Head and Neck (whatever the time lapse between the two irradiations)

• Pregnant and breastfeeding woman;

• Patients with pacemaker device

• Epileptic patients;

• Concomitant treatment or treatment within the 7 days before inclusion with one of several drugs from the following list: fluoroquinolones, cycline, methotrexate, auranofin

• Patients with ophthalmic diseases (such as maculopathy, retinopathy, glaucoma and cataract, retinal damage)

• Patients under judicial protection

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Device:
• Photobiomodulation session - intraoral
use of CareMin650TM lightbox(NeoMedLight) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose
• Photobiomodulation session - transcutaneous
use of ATP38® phototherapy device (Swiss Bio Inov Europe) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Until OM resolution, up to 12 weeks
Secondary	Radiotherapy treatment interruption in both group (intraoral and transcutaneous PBM)	Number of cancelled radiotherapy sessions in comparison to initial treatment plan	Until OM resolution, up to 12 weeks
Secondary	Duration of oral mucositis in both group (intraoral and transcutaneous PBM)	Number of days	Until OM resolution, up to 12 weeks
Secondary	Number of hospitals stays in both group (intraoral and transcutaneous PBM)	Number of unscheduled hospitalizations	Until OM resolution, up to 12 weeks
Secondary	Number of introductions of parenteral nutrition in both group (intraoral and transcutaneous PBM)	Number of days from radiotherapy initiation until artificial nutrition introduction	Until OM resolution, up to 12 weeks
Secondary	Infection rate in both group (intraoral and transcutaneous PBM)	Infections graded according to NCI-CTCAE V5.0 criteria	Until OM resolution, up to 12 weeks
Secondary	Food intake in both group (intraoral and transcutaneous PBM)	Measured on a weekly basis with the Simple Evaluation of Food Intake (SEFI) tool	Until OM resolution, up to 12 weeks
Secondary	Pain level in both group (intraoral and transcutaneous PBM)	Measured with a visual analogic scale (VAS), graded from 0 to 10	Until OM resolution, up to 12 weeks
Secondary	Quality of life of patients in both group (intraoral and transcutaneous PBM)	Questionnaire from EORTC: QLQ-C30 with organ specific QLQ-HN35 module	Until OM resolution, up to 12 weeks
Secondary	Dry mouth rate in both group (intraoral and transcutaneous PBM)	Graded according to NCI-CTCAE V5.0 criteria	Until OM resolution, up to 12 weeks