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 — RADIO-PBM

Head and Neck Neoplasms Clinical Trial

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

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Head and Neck Neoplasms

Clinical Trial Details

NCT number	NCT06458517
Study type	Interventional
Source	Institut de cancérologie Strasbourg Europe
Contact	Manon VOEGELIN
Phone	VOEGELIN
Email	promotion-rc@icans.eu
Status	Not yet recruiting
Phase	N/A
Start date	September 2, 2024
Completion date	May 2, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05980598` - TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma	Phase 2
Completed	`NCT02548377` - Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial	N/A
Active, not recruiting	`NCT02229656` - Olaparib and Radiotherapy in Head and Neck Cancer	Phase 1
Not yet recruiting	`NCT06289049` - Heavy Strength Training in Head and Neck Cancer Survivors	Phase 2
Not yet recruiting	`NCT06347185` - Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study	N/A
Terminated	`NCT02975739` - Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors	N/A
Recruiting	`NCT00982436` - Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer	Phase 1/Phase 2
Completed	`NCT01025518` - DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients	N/A
Active, not recruiting	`NCT00248235` - Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer	Phase 2/Phase 3
Terminated	`NCT00073450` - Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)	Phase 2
Completed	`NCT00135161` - Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer	Phase 1
Completed	`NCT05269342` - Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer	N/A
Recruiting	`NCT05544136` - A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer	Phase 2
Terminated	`NCT03286972` - PET/MRI to Enhance Precision Guidance in Head and Neck Radiation Treatment Planning
Recruiting	`NCT04435938` - A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck	Phase 2
Recruiting	`NCT03975465` - EMST and Swallowing in Long-Term Survivors of HNCA	N/A
Recruiting	`NCT03678649` - A Prospective Randomized Trial of Capecitabine Treatment in Patients With HNSCC	Phase 2
Completed	`NCT06446570` - Phase II Study of Durvalumab(MEDI4736) + Tremelimumab in Pulmonary Sarcomatoid Carcinoma	Phase 2
Completed	`NCT03292250` - Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]	Phase 2
Completed	`NCT02284802` - Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy	N/A