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Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children (CURALASE01)

Primary Purpose

Mucositis Oral

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
LLLT applied every other day
LLLT applied daily
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucositis Oral focused on measuring Children, Oral mucositis, Chemotherapy, Photobiomodulation

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University hospital of ToulouseRecruiting
  • University hospital of AngersRecruiting
  • University hospital of BesançonRecruiting
  • University hospital of GrenobleRecruiting
  • University hospital of LilleRecruiting
  • University hospital of LimogesRecruiting
  • Hôpital La TimoneRecruiting
  • University hospital of NancyRecruiting
  • University Hospital of NiceRecruiting
  • Armand Trousseau HospitalRecruiting
  • University hospital of PoitiersRecruiting
  • University hospital of ReimsRecruiting
  • University hospital of RouenRecruiting
  • University hospital of Saint-EtienneRecruiting
  • University hospital of StrasbourgRecruiting
  • University Hospital of ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LLLT applied every other day

LLLT applied daily

Arm Description

Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day

Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every day

Outcomes

Primary Outcome Measures

Session 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)

Secondary Outcome Measures

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.
Health insurance evaluation
Costs of inpatient hospital stays from the French health insurance perspective.
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).
OM occurrence
Occurrence of chemotherapy-induced OM of WHO grade 3 or 4 (deterioration of the clinical situation).
Feed evaluation
Occurrence of enteral feeding.
Analgesic consumption
Duration (in days) of consumption of step 2 and step 3 analgesics during chemotherapy-induced OM of WHO grade 2 or higher.
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.
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)
Adverse events occurrence
Occurrence of adverse events reported according to descriptions and grading scale found in NCI CTCAE version 5.0.
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.

Full Information

First Posted
September 4, 2020
Last Updated
September 20, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04596410
Brief Title
Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children
Acronym
CURALASE01
Official Title
Double-blind, Randomized, Multi-center, Non-inferiority Clinical Trial Comparing Two Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis Oral
Keywords
Children, Oral mucositis, Chemotherapy, Photobiomodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
406 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LLLT applied every other day
Arm Type
Experimental
Arm Description
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day
Arm Title
LLLT applied daily
Arm Type
Active Comparator
Arm Description
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every day
Intervention Type
Radiation
Intervention Name(s)
LLLT applied every other day
Intervention Description
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day
Intervention Type
Radiation
Intervention Name(s)
LLLT applied daily
Intervention Description
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied daily
Primary Outcome Measure Information:
Title
Session evaluation
Description
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)
Time Frame
Throught treatment period up to 1 month
Secondary Outcome Measure Information:
Title
Production costs evaluation
Description
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
Title
Health insurance evaluation
Description
Costs of inpatient hospital stays from the French health insurance perspective.
Time Frame
2 months
Title
OM duration evaluation
Description
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
Title
OM occurrence
Description
Occurrence of chemotherapy-induced OM of WHO grade 3 or 4 (deterioration of the clinical situation).
Time Frame
2 months
Title
Feed evaluation
Description
Occurrence of enteral feeding.
Time Frame
2 months
Title
Analgesic consumption
Description
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
Title
PBM evaluation
Description
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
Title
Pain change evaluation
Description
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
Title
Adverse events occurrence
Description
Occurrence of adverse events reported according to descriptions and grading scale found in NCI CTCAE version 5.0.
Time Frame
2 months
Title
thyroid-stimulating hormone (TSH) evolution
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female children aged ≥ 3 years and < 18 years. Hospitalization in an oncology or hematology department in the participating centres. Patients with oropharyngeal mucositis of grade 2 or higher (WHO grading system) related to cancer chemotherapy, including conditioning for Hematopoietic Stem Cell Transplantation (HSCT). Written informed consent of both patient's holders of parental authority, and patient's assent when applicable. Patients affiliated to a French Social Security insurance or equivalent social protection. Absence of any physical or psychological disability that may interfere with the LLLT application. Exclusion Criteria: Patients with a solid cancer lesion in the area of low-level laser application. History of cervicofacial radiotherapy. Application of low-level laser therapy for oral mucositis within 2 weeks prior to randomization. Hyperthyroidism defined by TSH < 0.4 IU/mL at inclusion. Patients susceptible to epilepsy seizure. Patients with pacemaker. 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. Patients protected by law (guardianship and safeguarding of justice). Pregnant female patients as determined by positive serum pregnancy test at screening. Lactating female patients who are actively breast feeding. Participation in another clinical trial involving oral care.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marlène PASQUET, MD
Phone
05 34 55 86 43
Ext
+33
Email
pasquet.m@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gwennaëlle ALPHONSA, CRA
Phone
05 67 77 13 94
Ext
+33
Email
alphonsa.g@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlène PASQUET
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Toulouse
City
Toulouse
State/Province
Occitanie
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlène PASQUET, MD
Phone
0534558643
Ext
+33
Email
pasquet.m@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Gwennaëlle ALPHONSA, CRA
Phone
05 67 77 13 94
Ext
+33
Email
alphonsa.g@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Cécile BOULANGER, MD
Facility Name
University hospital of Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle PELLIER, MD
First Name & Middle Initial & Last Name & Degree
Isabelle PELLIER, MD
Facility Name
University hospital of Besançon
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastien KLEIN, MD
First Name & Middle Initial & Last Name & Degree
Sebastien KLEIN
Facility Name
University hospital of Grenoble
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique PLANTAZ, MD
First Name & Middle Initial & Last Name & Degree
Dominique PLANTAZ
Facility Name
University hospital of Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wadih ABOU CHAHLA, MD
First Name & Middle Initial & Last Name & Degree
Wadih ABOU CHAHLA, MD
Facility Name
University hospital of Limoges
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline OUDOT, MD
First Name & Middle Initial & Last Name & Degree
Caroline OUDOT, MD
Facility Name
Hôpital La Timone
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur STERIN, MD
First Name & Middle Initial & Last Name & Degree
Arthur STERIN, MD
Facility Name
University hospital of Nancy
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie VALDUGA, MD
First Name & Middle Initial & Last Name & Degree
Julie VALDUGA, MD
Facility Name
University Hospital of Nice
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marilyne POIREE, MD
First Name & Middle Initial & Last Name & Degree
Marilyne POIREE, MD
Facility Name
Armand Trousseau Hospital
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine DOLLFUS, MD
First Name & Middle Initial & Last Name & Degree
Catherine DOLLFUS, MD
Facility Name
University hospital of Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chrystelle DUPRAZ, MD
First Name & Middle Initial & Last Name & Degree
Chrystelle DUPRAZ, MD
Facility Name
University hospital of Reims
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire PLUCHART, MD
First Name & Middle Initial & Last Name & Degree
Claire PLUCHART, MD
Facility Name
University hospital of Rouen
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie, MD
First Name & Middle Initial & Last Name & Degree
Marie JAFFRAY, MD
Facility Name
University hospital of Saint-Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine THOUVENIN -DOULET, MD
First Name & Middle Initial & Last Name & Degree
Sandrine THOUVENIN -DOULET, MD
Facility Name
University hospital of Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine PAILLARD, MD
First Name & Middle Initial & Last Name & Degree
Catherine PAILLARD, MD
Facility Name
University Hospital of Tours
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien, MD
First Name & Middle Initial & Last Name & Degree
Julien LEJEUNE, MD

12. IPD Sharing Statement

Learn more about this trial

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

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