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Using light therapy to relieve mouth pain from chemotherapy in children

Double-blind, Randomized, Multi-center, Non-inferiority Clinical Trial Comparing Two Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children

Not applicable Interventional University Hospital, Toulouse · NCT04596410

This study tests whether light therapy can help relieve mouth pain from chemotherapy in children aged 3 to 18 by comparing different treatment schedules.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment406 (estimated)
Ages3 Years to 17 Years
SexAll
SponsorUniversity Hospital, Toulouse Academic / other
Drugs / interventionschemotherapy
Locations16 sites (Toulouse, Occitanie and 15 other locations)
Trial IDNCT04596410 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of photobiomodulation (PBM) using low-level laser therapy (LLLT) to alleviate chemotherapy-induced oral mucositis in children aged 3 to 18 years. The study compares two different application protocols: LLLT applied every other day versus daily application. It aims to establish a standardized protocol for PBM in pediatric patients, addressing the variability in treatment parameters currently reported in the literature. The trial is multicenter, randomized, and double-blind, ensuring robust data collection and analysis.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 3 to 18 years who are hospitalized for cancer treatment and have oropharyngeal mucositis of grade 2 or higher.

Not a fit: Patients with solid cancer lesions in the area of laser application or those who have received prior low-level laser therapy for oral mucositis within two weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the quality of life for children undergoing chemotherapy by reducing pain and discomfort associated with oral mucositis.

How similar studies have performed: Previous studies have shown promising results for photobiomodulation in pediatric patients, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female children aged ≥ 3 years and \< 18 years.
2. Hospitalization in an oncology or hematology department in the participating centres.
3. Patients with oropharyngeal mucositis of grade 2 or higher (WHO grading system) related to cancer chemotherapy, including conditioning for Hematopoietic Stem Cell Transplantation (HSCT).
4. Written informed consent of both patient's holders of parental authority, and patient's assent when applicable.
5. Patients affiliated to a French Social Security insurance or equivalent social protection.
6. Absence of any physical or psychological disability that may interfere with the LLLT application.

Exclusion Criteria:

1. Patients with a solid cancer lesion in the area of low-level laser application.
2. History of cervicofacial radiotherapy.
3. Application of low-level laser therapy for oral mucositis within 2 weeks prior to randomization.
4. Hyperthyroidism defined by TSH \< 0.4 IU/mL at inclusion.
5. Patients susceptible to epilepsy seizure.
6. Patients with pacemaker.
7. Patients refusing to wear retinal goggles during low-level laser 1. Patients with a solid cancer lesion in the area of low-level laser application.
8. Patients protected by law (guardianship and safeguarding of justice).
9. Pregnant female patients as determined by positive serum pregnancy test at screening.
10. Lactating female patients who are actively breast feeding.
11. Participation in another clinical trial involving oral care.

Where this trial is running

Toulouse, Occitanie and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mucositis OralChildrenOral mucositisChemotherapyPhotobiomodulation
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.