Head and Neck NeoplasmsRADIO-PBMNCT06458517
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
A study testing Photobiomodulation session - intraoral and Photobiomodulation session - transcutaneous in people with Head and Neck Neoplasms, run by Centre Paul Strauss at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Photobiomodulation session - intraoral and Photobiomodulation session - transcutaneous
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2026to 15 Nov 2029
- Phase
- Interventional
- 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
Who may be able to join
- Adult patient (18 years old and older);
- Patients with oral cavity or oropharynx cancer treated with radiotherapy or chemo-radiotherapy;
- Karnofsky Performance Status > 60%;
- Able to understand French;
- With signed informed consent;
- Affiliated to French Health Security Insurance
Who cannot join
- Allergy to polyurethanes;
- Head and Neck tumors that are localized to other sites than oral cavity or oropharynx
- Previous irradiation of Head and Neck (whatever the time lapse between the two irradiations)
- Pregnant and breastfeeding woman;
- Patients with pacemaker device
- Epileptic patients;
Show all 9Show fewer
- Concomitant treatment or treatment within the 7 days before inclusion with one of several drugs from the following list: fluoroquinolones, cycline, methotrexate, auranofin
- Patients with ophthalmic diseases (such as maculopathy, retinopathy, glaucoma and cataract, retinal damage)
- Patients under judicial protection
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
Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
Manon VOEGELIN, 368339523 ext. +33, promotion-rc@icans.eu
About this study
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
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.
Read the detailed 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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Photobiomodulation session - intraoral, Photobiomodulation session - transcutaneous
- Keywords
- Radiotherapy, Chemotherapy, Photobiomodulation therapy, Low-level laser therapy, Oral mucositis
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation session - intraoralDevice
use of CareMin650TM lightbox(NeoMedLight) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose
Photobiomodulation session - transcutaneousDevice
use of ATP38® phototherapy device (Swiss Bio Inov Europe) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose
| Study group | Role | What they receive |
|---|---|---|
| Intraoral PBM | Other | Not described Receives: Device: Photobiomodulation session - intraoral |
| Transcutaneous PBM | Other | Not described Receives: Device: Photobiomodulation session - transcutaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of oral mucositis (grade ≥ 2) in both group (intraoral and transcutaneous PBM)
Oral mucositis will be graded according to NCI-CTCAE V5.0 criteria
Measured: Until OM resolution, up to 12 weeks
Secondary outcomes (9)
Radiotherapy treatment interruption in both group (intraoral and transcutaneous PBM)
Number of cancelled radiotherapy sessions in comparison to initial treatment plan
Measured: Until OM resolution, up to 12 weeks
Duration of oral mucositis in both group (intraoral and transcutaneous PBM)
Number of days
Measured: Until OM resolution, up to 12 weeks
Number of hospitals stays in both group (intraoral and transcutaneous PBM)
Number of unscheduled hospitalizations
Measured: Until OM resolution, up to 12 weeks
Number of introductions of parenteral nutrition in both group (intraoral and transcutaneous PBM)
Number of days from radiotherapy initiation until artificial nutrition introduction
Measured: Until OM resolution, up to 12 weeks
Infection rate in both group (intraoral and transcutaneous PBM)
Infections graded according to NCI-CTCAE V5.0 criteria
Measured: Until OM resolution, up to 12 weeks
Food intake in both group (intraoral and transcutaneous PBM)
Measured on a weekly basis with the Simple Evaluation of Food Intake (SEFI) tool
Measured: Until OM resolution, up to 12 weeks
Pain level in both group (intraoral and transcutaneous PBM)
Measured with a visual analogic scale (VAS), graded from 0 to 10
Measured: Until OM resolution, up to 12 weeks
Quality of life of patients in both group (intraoral and transcutaneous PBM)
Questionnaire from EORTC: QLQ-C30 with organ specific QLQ-HN35 module
Measured: Until OM resolution, up to 12 weeks
Dry mouth rate in both group (intraoral and transcutaneous PBM)
Graded according to NCI-CTCAE V5.0 criteria
Measured: Until OM resolution, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start15 Jun 2026 (estimated)
- Primary completion15 Nov 2029 (estimated)
- Study completion15 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordan EBER, MD, Principal investigator, Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458517
- Sponsor's protocol ID
- 2022-018
- Acronym
- RADIO-PBM
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eber J, Schohn A, Carinato H, Brahimi Y, Schmitt M, Noel G. A Pilot Study Comparing Intraoral and Transcutaneous Photobiomodulation for Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiotherapy or Chemoradiotherapy. J Clin Med. 2025 Apr 2;14(7):2430. doi: 10.3390/jcm14072430.
PubMed 40217880
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06458517
- Acronym / sponsor ID
- RADIO-PBM / 2022-018
- Conditions
- Head and Neck Neoplasms
- Keywords
- Radiotherapy, Chemotherapy, Photobiomodulation therapy, Low-level laser therapy, Oral mucositis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Nov 2029 (estimated)
- Study completion
- 15 Nov 2029 (estimated)
- First posted
- 13 Jun 2024 (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 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.
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoral PBM | Other | Device: Photobiomodulation session - intraoral |
| Transcutaneous PBM | Other | Device: Photobiomodulation session - transcutaneous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient (18 years old and older);
- Patients with oral cavity or oropharynx cancer treated with radiotherapy or chemo-radiotherapy;
- Karnofsky Performance Status > 60%;
- Able to understand French;
- With signed informed consent;
Key exclusion criteria (9 listed)
- Allergy to polyurethanes;
- Head and Neck tumors that are localized to other sites than oral cavity or oropharynx
- Previous irradiation of Head and Neck (whatever the time lapse between the two irradiations)
- Pregnant and breastfeeding woman;
- Patients with pacemaker device
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 |
|---|---|---|
| Photobiomodulation session - intraoraluse of CareMin650TM lightbox(NeoMedLight) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose | Device | Intraoral PBM |
| Photobiomodulation session - transcutaneoususe of ATP38® phototherapy device (Swiss Bio Inov Europe) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose | Device | Transcutaneous PBM |
Primary outcome
Cumulative incidence of oral mucositis (grade ≥ 2) in both group (intraoral and transcutaneous PBM)
Time frame: Until OM resolution, up to 12 weeks
Oral mucositis will be graded according to NCI-CTCAE V5.0 criteria
9 secondary outcomes
Radiotherapy treatment interruption in both group (intraoral and transcutaneous PBM)
Time frame: Until OM resolution, up to 12 weeks
Duration of oral mucositis in both group (intraoral and transcutaneous PBM)
Time frame: Until OM resolution, up to 12 weeks
Number of hospitals stays in both group (intraoral and transcutaneous PBM)
Time frame: Until OM resolution, up to 12 weeks
Number of introductions of parenteral nutrition in both group (intraoral and transcutaneous PBM)
Time frame: Until OM resolution, up to 12 weeks
Infection rate in both group (intraoral and transcutaneous PBM)
Time frame: Until OM resolution, up to 12 weeks
Food intake in both group (intraoral and transcutaneous PBM)
Time frame: Until OM resolution, up to 12 weeks
Pain level in both group (intraoral and transcutaneous PBM)
Time frame: Until OM resolution, up to 12 weeks
Quality of life of patients in both group (intraoral and transcutaneous PBM)
Time frame: Until OM resolution, up to 12 weeks
Dry mouth rate in both group (intraoral and transcutaneous PBM)
Time frame: Until OM resolution, up to 12 weeks
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 5 Jun 2026.
- Derived from this study: PubMed 40217880Eber J, Schohn A, Carinato H, Brahimi Y, Schmitt M, Noel G. A Pilot Study Comparing Intraoral and Transcutaneous Photobiomodulation for Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiotherapy or Chemoradiotherapy. J Clin Med. 2025 Apr 2;14(7):2430. doi: 10.3390/jcm14072430.
Related trials for Head and Neck Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Jordan EBER, MD principal investigator
Institut de cancérologie Strasbourg Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation session - intraoral and Photobiomodulation session - transcutaneous in people with Head and Neck Neoplasms, run by Centre Paul Strauss 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 5 Jun 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 Manon VOEGELIN (VOEGELIN ext. +33, promotion-rc@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of oral mucositis (grade ≥ 2) in both group (intraoral and transcutaneous PBM) (time frame: Until OM resolution, up to 12 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 NCT06458517, which also lists 1 linked publication.
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 5 Jun 2026.