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

NCT06458517 | Not Yet Recruiting

• 1 other identifier: 2022-018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms

Keywords

Radiotherapy; Chemotherapy; Photobiomodulation therapy; Low-level laser therapy; Oral 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

Study Arms (2)

Intraoral PBM

OTHER

Device: Photobiomodulation session - intraoral

Transcutaneous PBM

OTHER

Device: Photobiomodulation session - transcutaneous

Interventions

Photobiomodulation session - intraoral DEVICE

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

Intraoral PBM

Photobiomodulation session - transcutaneous DEVICE

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead

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: 40217880 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jordan EBER, MD

  Institut de cancérologie Strasbourg Europe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon VOEGELIN

CONTACT

VOEGELIN; promotion-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: September 2, 2024
• Primary Completion: May 2, 2026
• Study Completion: May 2, 2026
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

FR (1)