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

Production costs evaluation

Production costs from the hospital perspective and efficacy (i.e. number of days after which a child has no longer mucositis related pain as described in the primary endpoint section) to build Incremental Cost-Effectiveness Ratio (ICER) comparing every other day LLLT application versus with daily LLLT application.

Time frame: 2 months

Health insurance evaluation

Costs of inpatient hospital stays from the French health insurance perspective.

Time frame: 2 months

OM duration evaluation

Duration (in days) of chemotherapy-induced OM of WHO grade 2 or higher between the day of first PBM session up to the day of first measurement when patient has no longer WHO grade 2 or higher chemotherapy-induced OM at 2 consecutive measurements before the next scheduled PBM session (either every other day application or daily application).

Time frame: Throught treatment period up to 1 month

OM occurrence

Occurrence of chemotherapy-induced OM of WHO grade 3 or 4 (deterioration of the clinical situation).

Time frame: 2 months

Feed evaluation

Occurrence of enteral feeding.

Time frame: 2 months

Analgesic consumption

Duration (in days) of consumption of step 2 and step 3 analgesics during chemotherapy-induced OM of WHO grade 2 or higher.

Time frame: 2 months

PBM evaluation

Duration (in days) from the day of first PBM session up to the day of first measurement when patient has no longer WHO grade 2 or higher chemotherapy-induced OM related pain at 2 consecutive measurements before the next scheduled PBM session (either active laser application or matching placebo application) as evaluated, regardless of patient's age, with the ChIMES scale and use of step 3 analgesics.

Time frame: Through treatment period up to 1 month

Pain change evaluation

Change over time in WHO grade 2 or higher chemotherapy-induced OM related pain, as assessed by pain scales (HEDEN (Hétero Evaluation Douleur Enfant) mucositis scale (5 items ranging from 0 to 2) or VAS (ranging from 0 to 10)depending on patient's age category, and Children's International Mucositis Evaluation Scale (4 items ranging from 0 to 5) whatever patient's age category)

Time frame: From baseline to each day of PBM session

Adverse events occurrence

Occurrence of adverse events reported according to descriptions and grading scale found in NCI CTCAE version 5.0.

Time frame: 2 months

thyroid-stimulating hormone (TSH) evolution

TSH shift from baseline value classified according to the following three categories: "\< 0.4 IU/mL", "\[0.4 - 10\] IU/mL", "\> 10 IU/mL", to value at D14-31 after end of WHO grade 2 or higher chemotherapy-induced OM classified according to the same three categories.

Time frame: From baseline to 2 months