Head and Neck NeoplasmsCOH-PBM-3JNCT07899866
Determinants of Radiation Dermatitis in Head and Neck Cancer Patients Receiving Preventive Photobiomodulation
An observational study of Head and Neck Neoplasms and Radiodermatitis, run by Hopital Forcilles at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Radiodermatitis
- What is being tested?
- Preventive photobiomodulation, External beam radiotherapy and Functional, quality-of-life and photographic assessments
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2026to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
- 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.)
- Ongoing photosensitizing treatment that cannot be interrupted or replaced during radiotherapy
- Severe immunosuppression, defined in particular as HIV infection at the AIDS stage, long-term immunosuppressive treatment, or history of organ transplantation
- Concurrent participation in another therapeutic trial likely to affect the occurrence or severity of skin toxicity
Show all 9Show fewer
- Person under legal protection (guardianship, curatorship or safeguard of justice)
- Pregnant or breastfeeding woman
- Patient refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Forcilles - Fondation Cognacq-Jay
Férolles-Attilly, Seine-et-Marne, 77150
Romain PLOUZE
Michel GOZY, MD
About this study
Official title: Prospective Cohort Evaluating the Determinants of Radiation-Induced Skin Complications in Patients With Head and Neck Cancer Receiving Preventive Photobiomodulation
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Head and Neck Neoplasms, Radiodermatitis
- Being tested
- Preventive photobiomodulation, External beam radiotherapy, Functional, quality-of-life and photographic assessments
- Keywords
- Photobiomodulation, Low-Level Light Therapy, Radiotherapy, Radiation Injuries, Risk Factors, Quality of Life
- Medical subject headings
- Head and Neck Neoplasms, Radiodermatitis, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive photobiomodulationDevice
Also called ATP38
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.
External beam radiotherapyRadiation
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.
Functional, quality-of-life and photographic assessmentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Head and neck cancer patients receiving radiotherapy with preventive PBM | 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. Receives: Device: Preventive photobiomodulation; Radiation: External beam radiotherapy; Other: Functional, quality-of-life and photographic assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first to the last radiotherapy session, approximately 7 weeks
Secondary outcomes (15)
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of radiotherapy (week 6 to 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Forcilles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain PLOUZE, Principal investigator, Hôpital Forcilles - Fondation Cognacq-Jay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899866
- Sponsor's protocol ID
- 2026-A01480-51
- Other IDs
- 2026-03-01, 26.02715.000547
- Acronym
- COH-PBM-3J
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Behroozian T, Goldshtein D, Ryan Wolf J, van den Hurk C, Finkelstein S, Lam H, Patel P, Kanee L, Lee SF, Chan AW, Wong HCY, Caini S, Mahal S, Kennedy S, Chow E, Bonomo P; Multinational Association of Supportive Care in Cancer (MASCC) Oncodermatology Study Group Radiation Dermatitis Guidelines Working Group. MASCC clinical practice guidelines for the prevention and management of acute radiation dermatitis: part 1) systematic review. EClinicalMedicine. 2023 Mar 27;58:101886. doi: 10.1016/j.eclinm.2023.101886. eCollection 2023 Apr.
PubMed 37181415Robijns J, Nair RG, Lodewijckx J, Arany P, Barasch A, Bjordal JM, Bossi P, Chilles A, Corby PM, Epstein JB, Elad S, Fekrazad R, Fregnani ER, Genot MT, Ibarra AMC, Hamblin MR, Heiskanen V, Hu K, Klastersky J, Lalla R, Latifian S, Maiya A, Mebis J, Migliorati CA, Milstein DMJ, Murphy B, Raber-Durlacher JE, Roseboom HJ, Sonis S, Treister N, Zadik Y, Bensadoun RJ. Photobiomodulation therapy in management of cancer therapy-induced side effects: WALT position paper 2022. Front Oncol. 2022 Aug 30;12:927685. doi: 10.3389/fonc.2022.927685. eCollection 2022.
PubMed 36110957Gobbo M, Rico V, Marta GN, Caini S, Ryan Wolf J, van den Hurk C, Beveridge M, Lam H, Bonomo P, Chow E, Behroozian T. Photobiomodulation therapy for the prevention of acute radiation dermatitis: a systematic review and meta-analysis. Support Care Cancer. 2023 Mar 23;31(4):227. doi: 10.1007/s00520-023-07673-y.
PubMed 36952036Robijns J, Lodewijckx J, Claes S, Van Bever L, Pannekoeke L, Censabella S, Busse L, Colson D, Kaminski I, Broux V, Puts S, Vanmechelen S, Timmermans A, Noe L, Bulens P, Govers M, Maes A, Mebis J. Photobiomodulation therapy for the prevention of acute radiation dermatitis in head and neck cancer patients (DERMISHEAD trial). Radiother Oncol. 2021 May;158:268-275. doi: 10.1016/j.radonc.2021.03.002. Epub 2021 Mar 10.
PubMed 33711412
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Evaluating the Determinants of Radiation-Induced Skin Complications in Patients With Head and Neck Cancer Receiving Preventive Photobiomodulation
- ClinicalTrials.gov ID
- NCT07899866
- Acronym / sponsor ID
- COH-PBM-3J / 2026-A01480-51
- Conditions
- Head and Neck Neoplasms, Radiodermatitis
- Keywords
- Photobiomodulation, Low-Level Light Therapy, Radiotherapy, Radiation Injuries, Risk Factors, Quality of Life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hopital ForcillesUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and neck cancer patients receiving radiotherapy with preventive PBM | – | Device: Preventive photobiomodulation, Radiation: External beam radiotherapy, Other: Functional, quality-of-life and photographic assessmentsAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- 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.)
- Ongoing photosensitizing treatment that cannot be interrupted or replaced during radiotherapy
- Severe immunosuppression, defined in particular as HIV infection at the AIDS stage, long-term immunosuppressive treatment, or history of organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventive photobiomodulationAlso: ATP38Delivered 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. | Device | Head and neck cancer patients receiving radiotherapy with preventive PBM |
| External beam radiotherapyStandard 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. | Radiation | Head and neck cancer patients receiving radiotherapy with preventive PBM |
| Functional, quality-of-life and photographic assessmentsProcedures 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. | Other | Head and neck cancer patients receiving radiotherapy with preventive PBM |
Primary outcome
Number of Participants With Grade 2 or Higher Radiation Dermatitis Assessed by NCI-CTCAE v5.0
Time frame: From the first to the last radiotherapy session, approximately 7 weeks
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.
15 secondary outcomes
Number of Participants With Grade 3 or Higher Radiation Dermatitis Assessed by NCI-CTCAE v5.0
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 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 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
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
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
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
Time frame: From the first to the last PBM session, approximately 7 weeks
Number of PBM-Related Adverse Events by Type
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
Time frame: From the first to the last PBM session, approximately 7 weeks
Handgrip Strength
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
Time frame: At inclusion (before radiotherapy) and at the end of radiotherapy (approximately 7 weeks)
Number of Participants With Malnutrition According to HAS Criteria
Time frame: At inclusion, during radiotherapy and at the end of radiotherapy (approximately 7 weeks)
Pain Intensity Assessed by Visual Analog Scale
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
Time frame: From the first to the last radiotherapy session, approximately 7 weeks
EORTC QLQ-H&N35 Scores at the End of Radiotherapy
Time frame: At the end of radiotherapy (week 6 to 7)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 37181415Behroozian T, Goldshtein D, Ryan Wolf J, van den Hurk C, Finkelstein S, Lam H, Patel P, Kanee L, Lee SF, Chan AW, Wong HCY, Caini S, Mahal S, Kennedy S, Chow E, Bonomo P; Multinational Association of Supportive Care in Cancer (MASCC) Oncodermatology Study Group Radiation Dermatitis Guidelines Working Group. MASCC clinical practice guidelines for the prevention and management of acute radiation dermatitis: part 1) systematic review. EClinicalMedicine. 2023 Mar 27;58:101886. doi: 10.1016/j.eclinm.2023.101886. eCollection 2023 Apr.
- Background: PubMed 36110957Robijns J, Nair RG, Lodewijckx J, Arany P, Barasch A, Bjordal JM, Bossi P, Chilles A, Corby PM, Epstein JB, Elad S, Fekrazad R, Fregnani ER, Genot MT, Ibarra AMC, Hamblin MR, Heiskanen V, Hu K, Klastersky J, Lalla R, Latifian S, Maiya A, Mebis J, Migliorati CA, Milstein DMJ, Murphy B, Raber-Durlacher JE, Roseboom HJ, Sonis S, Treister N, Zadik Y, Bensadoun RJ. Photobiomodulation therapy in management of cancer therapy-induced side effects: WALT position paper 2022. Front Oncol. 2022 Aug 30;12:927685. doi: 10.3389/fonc.2022.927685. eCollection 2022.
- Background: PubMed 36952036Gobbo M, Rico V, Marta GN, Caini S, Ryan Wolf J, van den Hurk C, Beveridge M, Lam H, Bonomo P, Chow E, Behroozian T. Photobiomodulation therapy for the prevention of acute radiation dermatitis: a systematic review and meta-analysis. Support Care Cancer. 2023 Mar 23;31(4):227. doi: 10.1007/s00520-023-07673-y.
- Background: PubMed 33711412Robijns J, Lodewijckx J, Claes S, Van Bever L, Pannekoeke L, Censabella S, Busse L, Colson D, Kaminski I, Broux V, Puts S, Vanmechelen S, Timmermans A, Noe L, Bulens P, Govers M, Maes A, Mebis J. Photobiomodulation therapy for the prevention of acute radiation dermatitis in head and neck cancer patients (DERMISHEAD trial). Radiother Oncol. 2021 May;158:268-275. doi: 10.1016/j.radonc.2021.03.002. Epub 2021 Mar 10.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Romain PLOUZE principal investigator
Hôpital Forcilles - Fondation Cognacq-Jay
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms and Radiodermatitis, run by Hopital Forcilles at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreia GOMES LOPES (+33160646293, alopes@cognacq-jay.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Grade 2 or Higher Radiation Dermatitis Assessed by NCI-CTCAE v5.0 (time frame: From the first to the last radiotherapy session, approximately 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07899866, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.