NCT04596410

Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis 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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 406 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Chemotherapy-induced oropharyngeal mucositis (OM) negatively impacts the quality of life of adult and pediatric patients by causing pain, dysphagia, dysgeusia and dysphonia. Photobiomodulation (PBM) by low level laser therapy (LLLT), light therapy of low level of red and infrared wavelengths (630-1000 nm) has been recommended since 2014 in patients treated with high-dose chemotherapy for bone marrow transplantation. Available pediatric studies highlighted positive/promising results of PBM with excellent safety and no adverse effects. Nevertheless, a wide variety of application parameters is described in the literature, with no consensus guidelines. Considering the lack of standardized protocol of photobiomodulation in the pediatric population as well as the burden and cost of a daily application, investigators have decided to conduct, for the first time in children of 3 years of age or older, a multicenter, randomized, double-blind, non-inferiority clinical trial to compare two PBM protocols with same PBM parameters, combining red and infrared wavelengths, but with different frequencies of laser application (daily versus every other day), in the treatment of chemotherapy-induced OM of WHO grade 2 or higher.

Conditions

• Mucositis Oral

Interventions

Type	Name	Description
RADIATION	LLLT applied every other day	Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day
RADIATION	LLLT applied daily	Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied daily

Timeline

• Start date: 2021-05-03
• Primary completion: 2024-01-01
• Completion: 2024-02-01
• First posted: 2020-10-22
• Last updated: 2023-09-22

Locations

16 sites across 1 country: France