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

Trial Title: 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

NCT ID: NCT06458517

Condition: Head and Neck Neoplasms

Conditions: Official terms:
Head and Neck Neoplasms

Conditions: Keywords:
Radiotherapy
Chemotherapy
Photobiomodulation therapy
Low-level laser therapy
Oral mucositis

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Photobiomodulation session - intraoral
Description: use of CareMin650TM lightbox(NeoMedLight) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose
Arm group label: Intraoral PBM

Intervention type: Device
Intervention name: Photobiomodulation session - transcutaneous
Description: use of ATP38® phototherapy device (Swiss Bio Inov Europe) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose
Arm group label: Transcutaneous PBM

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Institut de cancérologie Strasbourg Europe

Address:
City: Strasbourg
Zip: 67033
Country: France

Contact:
Last name: Manon VOEGELIN

Phone: 368339523

Phone ext: +33
Email: promotion-rc@icans.eu

Start date: September 2, 2024

Completion date: May 2, 2026

Lead sponsor:
Agency: Institut de cancérologie Strasbourg Europe
Agency class: Other

Source: Institut de cancérologie Strasbourg Europe

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06458517