Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children

Last updated: September 20, 2023
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mucositis

Treatment

LLLT applied daily

LLLT applied every other day

Clinical Study ID

NCT04596410
RC31/19/0556
  • Ages 3-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 CellTransplantation (HSCT).
  4. Written informed consent of both patient's holders of parental authority, andpatient's assent when applicable.
  5. Patients affiliated to a French Social Security insurance or equivalent socialprotection.
  6. Absence of any physical or psychological disability that may interfere with the LLLTapplication.

Exclusion

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 torandomization.
  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 asolid 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.

Study Design

Total Participants: 406
Treatment Group(s): 2
Primary Treatment: LLLT applied daily
Phase:
Study Start date:
May 03, 2021
Estimated Completion Date:
February 29, 2024

Connect with a study center

  • University hospital of Toulouse

    Toulouse, Occitanie 31000
    France

    Active - Recruiting

  • University hospital of Angers

    Angers,
    France

    Active - Recruiting

  • University hospital of Besançon

    Besançon,
    France

    Active - Recruiting

  • University hospital of Grenoble

    Grenoble,
    France

    Active - Recruiting

  • University hospital of Lille

    Lille,
    France

    Active - Recruiting

  • University hospital of Limoges

    Limoges,
    France

    Active - Recruiting

  • Hôpital La Timone

    Marseille,
    France

    Active - Recruiting

  • University hospital of Nancy

    Nancy,
    France

    Active - Recruiting

  • University Hospital of Nice

    Nice,
    France

    Active - Recruiting

  • Armand Trousseau Hospital

    Paris,
    France

    Active - Recruiting

  • University hospital of Poitiers

    Poitiers,
    France

    Active - Recruiting

  • University hospital of Reims

    Reims,
    France

    Active - Recruiting

  • University hospital of Rouen

    Rouen,
    France

    Active - Recruiting

  • University hospital of Saint-Etienne

    Saint-Étienne,
    France

    Active - Recruiting

  • University hospital of Strasbourg

    Strasbourg,
    France

    Active - Recruiting

  • University Hospital of Tours

    Tours,
    France

    Active - Recruiting

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