NCT06458517

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
40mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Nov 2029

First Submitted

Initial submission to the registry

June 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
2 years until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2029

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

3.4 years

First QC Date

June 10, 2024

Last Update Submit

June 4, 2026

Conditions

Head and Neck Neoplasms

Keywords

RadiotherapyChemotherapyPhotobiomodulation therapyLow-level laser therapyOral mucositis

Outcome Measures

Primary Outcomes (1)

  • 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

    Until OM resolution, up to 12 weeks

Secondary Outcomes (9)

  • Radiotherapy treatment interruption in both group (intraoral and transcutaneous PBM)

    Until OM resolution, up to 12 weeks

  • Duration of oral mucositis in both group (intraoral and transcutaneous PBM)

    Until OM resolution, up to 12 weeks

  • Number of hospitals stays in both group (intraoral and transcutaneous PBM)

    Until OM resolution, up to 12 weeks

  • Number of introductions of parenteral nutrition in both group (intraoral and transcutaneous PBM)

    Until OM resolution, up to 12 weeks

  • Infection rate in both group (intraoral and transcutaneous PBM)

    Until OM resolution, up to 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Intraoral PBM

OTHER
Device: Photobiomodulation session - intraoral

Transcutaneous PBM

OTHER
Device: Photobiomodulation session - transcutaneous

Interventions

Photobiomodulation session - intraoralDEVICE

use of CareMin650TM lightbox(NeoMedLight) in preventive and in case of occurence of grade 1 oral mucositis, in curative purpose

Intraoral PBM
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

Transcutaneous PBM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • Patients with ophthalmic diseases (such as maculopathy, retinopathy, glaucoma and cataract, retinal damage)
  • Patients under judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location

Related Publications (1)

  • 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.

    PMID: 40217880DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsStomatitis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Jordan EBER, MD

    Institut de cancérologie Strasbourg Europe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon VOEGELIN

CONTACT

VOEGELINpromotion-rc@icans.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 13, 2024

Study Start

June 15, 2026

Primary Completion (Estimated)

November 15, 2029

Study Completion (Estimated)

November 15, 2029

Last Updated

June 5, 2026

Record last verified: 2026-06

Locations

FR(1)