Oral Mucositis Clinical Trial
Official title:
Evaluation of Low-energy Laser Therapy for Prevention and Reduction of Severity of Oral Mucositis in Children "Mucositis Laser 1"
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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