Clinical trial NCT01007617: Low-energy Laser Therapy for Prevention of Oral Mucositis in Children
Official title: Evaluation of Low-energy Laser Therapy for Prevention and Reduction of Severity of Oral Mucositis in Children "Mucositis Laser 1"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Oral Mucositis
Keywords: Children
Cancer
Mucositis
Laser
Prevention
Chemotherapy
Children with malignancies receiving chemotherapy and/or radiotherapy inducing severe mucositis
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Centre Régional de Cancérologie et Thérapie Cellulaire Pédiatrique, CHU de Clermont-Ferrand
name: Faculté de chirurgie dentaire, Clermont-Ferrand
name: Centre de Pharmacologie Clinique, INSERM CIC 501
name: Laboratoire des Matériaux Inorganiques, ESA CNRS 6002 et ENSCCF, Université Blaise-Pascal, Aubière
First posted: 2009-11-04
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Oral mucositis represents a major complication of cytotoxic chemotherapy among cancer in children. Low-power laser therapy (LPLT) has been used to reduce the incidence of oral mucositis in patients who are receiving high-dose chemotherapy. The aim of this study is to compare two preventives energies delivered of LPLT to oral mucosa in decreasing the severity of mucositis in children.

Detailed description: Mucositis is one of the main complications of cytotoxic chemotherapy and total body irradiation in children cancers. Local and systemic treatments are not efficiency or limited by side effects, (particularly for opioid). Two randomized recent studies in adult have showed the efficiency of LPLT (wavelength 650nm at the intensity of 4J/cm²) in prevention of severe mucositis. In pediatrics patient, only one randomized study was performed to the same intensity of 4J/cm² but with a wavelength of 732nm, and did not show the evidence of profit. In theory, tissues absorption level of laser is similar at 650 and 900nm but lower around 700nm. Procedure was very well tolerated by children; the main limiting factor is the deadline directly proportional to intensity delivered.

The aim of our study is to compare two preventives energies (2J/cm² or 8 J/cm²) daily delivered of LPLT to oral mucosa in decreasing the severity of mucositis in children. Placebo study was not possible to our opinion and we preferred to compare two intensity of LPLT for three reasons : being given the sensation of heat generated by the treatment, a true placebo is difficult to obtain; considering the difficulties proceeding to large-sized clinical trials in this population, it seems to us necessary to end quickly in an optimal protocol; the main inconvenience of LPLT is the duration of the sessions, so in case of negative result, our study will generate data allowing not to realize useless too long sessions.

It's a prospective controlled study, randomized in double blind phase II, in one center. All the patients will receive LPLT (GaAlAs, wavelength 980nm) daily of the 1st in the 5th day of cytotoxic treatment. The patients will be randomized in 2 groups according to the delivered dose: 2 J/cm2/d or 8 J/cm2/d.

Main evaluation criteria: mucositis maximal intensity (WHO scale) Secondary evaluation criteria: mucositis duration, mucositis survival free, pain, opioid treatment, hospitalization, fever and infection, nutrition.

Expected clinical effects: improvement of the children's comfort; dissemination of the technique in the other oncology pediatric centers

Eligibility criteria: Inclusion Criteria:

* 0 at 18 years
* patients receiving therapy with agents likely to cause severe mucositis (grade 3 or 4)
* Patients who had developed severe mucositis previously in any chemotherapy, and receiving the same.
* Healthy oral mucosa
* informed consent

Exclusion Criteria:

* - Infection active and proved, viral, bacterial or fungal oral cavity
* Malignant pathology in the oral cavity
* Preliminary local irradiation of the oral cavity
* Simultaneous treatment by an agent of prevention or treatment of mucositis in investigation
* Inclusion in a protocol with oral mucositis as one of the assessment criteria
* Absence of consent lit by parents or child

Primary outcomes:
measure: Mucositis scale - World Health Organization (WHO)
timeFrame: after delivering a dose of 2 J/cm2/d
Secondary outcomes:
measure: Mucositis period
timeFrame: after delivering a dose of 8 J/cm2/d
measure: Mucositis free survival
timeFrame: after delivering a dose of 8 J/cm2/d
measure: Pain intensity
timeFrame: after delivering a dose of 8 J/cm2/d
measure: Morphinic administration
timeFrame: after delivering a dose of 8 J/cm2/d
measure: Duration of hospitalisation
timeFrame: after delivering a dose of 8 J/cm2/d
measure: Febrile neutropenia
timeFrame: after delivering a dose of 8 J/cm2/d
measure: Duration of parenteral nutrition
timeFrame: after delivering a dose of 8 J/cm2/d
measure: Psychological impact
timeFrame: after delivering a dose of 8 J/cm2/d
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Etienne MERLIN, MD
role: PRINCIPAL_INVESTIGATOR
References: