NCT07899866Not yet recruiting
Determinants of Radiation Dermatitis in Head and Neck Cancer Patients Receiving Preventive Photobiomodulation
Prospective Cohort Evaluating the Determinants of Radiation-Induced Skin Complications in Patients With Head and Neck Cancer Receiving Preventive Photobiomodulation
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 20 Oct 2026
- Start date
- 2 Nov 2026
- Primary completion date
- Nov 2028
- Lead sponsor
- Hopital Forcilles
- Diseases
- Head and neck cancer
- NCT number
- NCT07899866
What you commit to
- Study type: Observational
- Planned participants: 150
- From 2 Nov 2026 to the primary completion date, Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to receive PBM due to a contraindication, patient refusal, or radiotherapy duration of less than two weeks
- Previous radiotherapy to the cervico-facial region
- Ongoing photosensitizing treatment that cannot be interrupted or replaced during radiotherapy
- Concurrent participation in another therapeutic trial likely to affect the occurrence or severity of skin toxicity
Other illness
- Uncontrolled or active dermatological condition in the area to be irradiated likely to interfere with the assessment of skin toxicity (psoriasis, eczema, cutaneous lupus, etc.)
- Severe immunosuppression, defined in particular as HIV infection at the AIDS stage, long-term immunosuppressive treatment, or history of organ transplantation
Other
- Person under legal protection (guardianship, curatorship or safeguard of justice)
- Pregnant or breastfeeding woman
- Patient refusal to participate in the study
Who the study is looking for
- Age 18 years or older at the time of inclusion
- Diagnosis of head and neck cancer (histological, cytological or imaging confirmation), including the following sites: oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity and paranasal sinuses
- Indication for curative-intent external beam radiotherapy (exclusive or adjuvant), with or without concomitant chemotherapy, exposing the cervical skin
- Possibility of starting preventive photobiomodulation (PBM) from the start of radiotherapy according to the standardized protocol (3 sessions/week, 3 J/cm2)
- Affiliated with or beneficiary of a social security scheme
- Free, informed and express written consent obtained after provision of an information sheet
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Forcilles - Fondation Cognacq-Jay Coordinator of this site? Confirm its status | Férolles-Attilly | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.