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NOT YET RECRUITING
NCT07899866

Determinants of Radiation Dermatitis in Head and Neck Cancer Patients Receiving Preventive Photobiomodulation

Sponsor: Hopital Forcilles

View on ClinicalTrials.gov

Summary

The goal of this observational study is to identify factors associated with the occurrence of grade 2 or higher radiation dermatitis in adults with head and neck cancer treated with radiotherapy who receive preventive photobiomodulation (PBM) as part of their standard care. The main question it aims to answer is: which clinical, demographic, tumor-related, treatment-related and functional factors are associated with grade 2 or higher radiation dermatitis (NCI-CTCAE v5.0) despite preventive PBM? Participants will receive their usual radiotherapy and their usual preventive PBM sessions (3 sessions per week throughout radiotherapy). In addition, for the purpose of the study, they will: * perform a 1-minute sit-to-stand test and a handgrip strength measurement at inclusion and at the end of radiotherapy; * complete the EORTC QLQ-H\&N35 quality-of-life questionnaire before radiotherapy, at mid-treatment and at the end of radiotherapy; * have standardized photographs taken of the irradiated skin. Skin toxicity will be graded at each PBM session.

Official title: Prospective Cohort Evaluating the Determinants of Radiation-Induced Skin Complications in Patients With Head and Neck Cancer Receiving Preventive Photobiomodulation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2026-11-02

Completion Date

2028-11

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DEVICE

Preventive photobiomodulation

Delivered as part of standard care (not assigned by the study) with the ATP38 device (Swiss Bio Inov, CE-marked class IIa): 800-835 nm, 3 J/cm2 per zone, 40 mm without contact, 3 sessions per week, 30 to 120 minutes before the radiotherapy fraction, throughout radiotherapy (18-21 sessions), on the cervical (anterior and lateral) and submandibular regions.

RADIATION

External beam radiotherapy

Standard care, not assigned by the study: curative-intent radiotherapy (exclusive or adjuvant, with or without concomitant chemotherapy), generally 30 to 35 fractions, 5 fractions per week, volumetric modulated arc therapy.

OTHER

Functional, quality-of-life and photographic assessments

Procedures added by the study: 1-minute sit-to-stand test and handgrip strength at inclusion and at the end of radiotherapy; EORTC QLQ-H\&N35 questionnaire at inclusion, at week 3 and at the end of radiotherapy; standardized photographs of the irradiated skin at inclusion, weeks 1, 3 and 5, and at the end of radiotherapy.

Locations (1)

Hôpital Forcilles - Fondation Cognacq-Jay

Férolles-Attilly, Seine-et-Marne, France