An observational study in Head and Neck Neoplasms and Radiodermatitis, sponsored by Hopital Forcilles. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Hopital Forcilles · Observational
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:
Head and neck cancers are frequently treated with radiotherapy, which commonly causes acute radiation dermatitis. Preventive photobiomodulation (PBM) is recommended by MASCC (2023) and WALT for the prevention of radiation dermatitis and is part of standard care in the radiotherapy department of Hopital Forcilles. However, a proportion of patients still develop grade 2 or higher radiation dermatitis despite PBM, and the determinants of this partial response are poorly characterized.
COH-PBM-3J is a prospective, single-center cohort study (French Category 2 research involving human participants, with minimal risks and constraints). Consecutive eligible patients are included before the start of radiotherapy. PBM is delivered as part of standard care with the ATP38 device (Swiss Bio Inov; CE-marked class IIa medical device) at 800-835 nm, 3 J/cm2 per zone, at 40 mm without contact, 3 sessions per week (Monday-Wednesday-Friday), 30 to 120 minutes before the radiotherapy fraction, throughout radiotherapy (6-7 weeks, 18-21 sessions), on the cervical (anterior and lateral) and submandibular regions. Delivered parameters, compliance, interval between PBM and radiotherapy, adverse events and skin toxicity grade are recorded at each session. The irradiated skin surface is extracted from the treatment planning system (Eclipse) to calculate the cumulative PBM energy (fluence x surface x number of sessions performed).
Candidate factors include age, sex, Fitzpatrick skin phototype, comorbidities, nutritional and functional status, smoking, alcohol use, tumor site, TNM stage, histology, radiotherapy technique, total dose and dose per fraction, irradiated volumes, doses to organs at risk, concomitant chemotherapy, PBM compliance and cumulative PBM energy.
The sample size (150 patients, 135 analyzable assuming 10% losses) is based on the events-per-variable rule (EPV >= 10), with an expected incidence of grade 2 or higher radiation dermatitis of 23-30%. The primary analysis uses univariate tests followed by a parsimonious multivariable logistic regression. Secondary analyses include Kaplan-Meier and Cox models (time to onset), ordinal logistic regression (severity), restricted cubic splines (PBM dose-response), a per-protocol sensitivity analysis (patients receiving at least 80% of planned PBM sessions), exploratory subgroup analyses with interaction terms, mixed models for quality of life, and multiple imputation for missing data.
2,409 studies on the registry are indexed under Head and Neck Neoplasms; 562 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 456 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Hopital Forcilles is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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Adult patients with head and neck cancer treated with curative-intent radiotherapy and preventive photobiomodulation in the radiotherapy department of Hopital Forcilles (single center), recruited prospectively and consecutively.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adults with head and neck cancer treated with curative-intent external beam radiotherapy (exclusive or adjuvant, with or without concomitant chemotherapy) exposing the cervical skin, who receive preventive photobiomodulation as part of standard care.
Device: Preventive photobiomodulation · Radiation: External beam radiotherapy · Other: Functional, quality-of-life and photographic assessments
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.
Also known as: ATP38
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.
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.
Number of Participants With Grade 2 or Higher Radiation Dermatitis Assessed by NCI-CTCAE v5.0
Occurrence of radiation dermatitis of grade 2 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 (moderate to brisk erythema, moist desquamation mostly confined to skin folds and/or moderate edema, or worse), assessed at each PBM session (3 times per week). Clinical, demographic, tumor-related, treatment-related and PBM-related factors associated with this outcome will be identified by univariate analyses and multivariable logistic regression.
Time frame: From the first to the last radiotherapy session, approximately 7 weeks
Number of Participants With Grade 3 or Higher Radiation Dermatitis Assessed by NCI-CTCAE v5.0
Occurrence of severe radiation dermatitis (grade 3 or higher according to NCI-CTCAE version 5.0), assessed at each PBM session (3 times per week).
Time frame: From the first to the last radiotherapy session, approximately 7 weeks
Time to Onset of the First Grade 2 or Higher Radiation Dermatitis
Time in days between the start of radiotherapy and the first radiation dermatitis of grade 2 or higher (NCI-CTCAE v5.0). Participants without the event are censored at the end of follow-up.
Time frame: From the start of radiotherapy to the first grade 2 or higher radiation dermatitis, assessed up to the end of radiotherapy (approximately 7 weeks)
Duration of Grade 2 or Higher Radiation Dermatitis
Time in days between the date of the first radiation dermatitis of grade 2 or higher (NCI-CTCAE v5.0) and the date of return to a grade lower than 2 (or disappearance of clinical signs as documented).
Time frame: From the first grade 2 or higher radiation dermatitis to return to grade lower than 2, assessed up to the end of radiotherapy (approximately 7 weeks)
Number of Participants With an Unplanned Radiotherapy Interruption of at Least 5 Consecutive Days Attributable to Radiation Dermatitis
Unplanned interruption of radiotherapy lasting 5 or more consecutive days attributable to radiation dermatitis (yes/no).
Time frame: From the first to the last radiotherapy session, approximately 7 weeks
Number of Participants With a Radiotherapy Dose Reduction of at Least 10% Attributable to Radiation Dermatitis
Reduction of the radiotherapy dose of 10% or more attributable to radiation dermatitis (yes/no).
Time frame: From the first to the last radiotherapy session, approximately 7 weeks
Number of Participants With at Least One Postponed Radiotherapy Session Attributable to Radiation Dermatitis
At least one radiotherapy session postponed because of radiation dermatitis (yes/no).
Time frame: From the first to the last radiotherapy session, approximately 7 weeks
Number of Participants With at Least One Adverse Event Related or Possibly Related to PBM
Adverse events related or possibly related to photobiomodulation, collected during and after each PBM session (expected events include local discomfort, sensation of heat, tingling/paresthesia, transient post-PBM erythema, local skin dryness and pruritus).
Time frame: From the first to the last PBM session, approximately 7 weeks
Number of PBM-Related Adverse Events by Type
Descriptive typology of adverse events related or possibly related to photobiomodulation (e.g. local discomfort, sensation of heat, tingling, transient erythema, local skin dryness, pruritus), as collected during and after each PBM session.
Time frame: From the first to the last PBM session, approximately 7 weeks
Number of PBM-Related Adverse Events by Severity Assessed by NCI-CTCAE v5.0
Severity of adverse events related or possibly related to photobiomodulation, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, as collected during and after each PBM session.
Time frame: From the first to the last PBM session, approximately 7 weeks
Handgrip Strength
Maximal handgrip strength (kg) measured with a hydraulic dynamometer. Higher values indicate greater strength. The association between handgrip strength and the presence of grade 2 or higher radiation dermatitis will be explored.
Time frame: At inclusion (before radiotherapy) and at the end of radiotherapy (approximately 7 weeks)
Number of Chair Rises in the 1-Minute Sit-to-Stand Test
Number of sit-to-stand repetitions performed in 60 seconds. Higher values indicate better functional capacity. The association with the presence of grade 2 or higher radiation dermatitis will be explored.
Time frame: At inclusion (before radiotherapy) and at the end of radiotherapy (approximately 7 weeks)
Number of Participants With Malnutrition According to HAS Criteria
Malnutrition diagnosed according to the French National Authority for Health (HAS 2019 for adults under 70 years, HAS 2021 for adults 70 years or older) criteria: at least one phenotypic criterion and at least one etiological criterion; severity graded as moderate or severe. The association with the presence of grade 2 or higher radiation dermatitis will be explored.
Time frame: At inclusion, during radiotherapy and at the end of radiotherapy (approximately 7 weeks)
Pain Intensity Assessed by Visual Analog Scale
Pain intensity on a visual analog scale (VAS) from 0 (no pain) to 10 (worst pain); higher scores indicate more pain. The association with the presence of grade 2 or higher radiation dermatitis will be explored.
Time frame: At inclusion, at each PBM session during radiotherapy and at the end of radiotherapy (approximately 7 weeks)
Number of Participants Using Opioid Analgesics
Use of opioid analgesics (yes/no). The association with the presence of grade 2 or higher radiation dermatitis will be explored.
Time frame: From the first to the last radiotherapy session, approximately 7 weeks
EORTC QLQ-H&N35 Scores at the End of Radiotherapy
Total score and relevant subscales (swallowing, mouth pain, dry mouth, mouth opening) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck module (QLQ-H\&N35). Items are scored from 1 to 4 and transformed to 0-100 scales according to the EORTC scoring manual; higher scores indicate a higher level of symptoms. Scores will be compared between participants with and without grade 2 or higher radiation dermatitis.
Time frame: At the end of radiotherapy (week 6 to 7)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The protocol, the statistical analysis plan and data will be available as supplementary materials with the publication. The other data that support the findings of this study will be available from the corresponding author upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: At publication for 10 years
Access criteria: The data that support the findings of this study will be available from the corresponding author upon reasonable request.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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