Low-energy Laser Therapy for Prevention of Oral Mucositis in Children

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.

Study Overview

• Status: Unknown
• Conditions: Oral Mucositis
• Intervention / Treatment: Device: LLLT :low level laser therapy

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mucositis scale - World Health Organization (WHO)	after delivering a dose of 2 J/cm2/d

Secondary Outcome Measures

Outcome Measure	Time Frame
Mucositis period	after delivering a dose of 8 J/cm2/d
Mucositis free survival	after delivering a dose of 8 J/cm2/d
Pain intensity	after delivering a dose of 8 J/cm2/d
Morphinic administration	after delivering a dose of 8 J/cm2/d
Duration of hospitalisation	after delivering a dose of 8 J/cm2/d
Febrile neutropenia	after delivering a dose of 8 J/cm2/d
Duration of parenteral nutrition	after delivering a dose of 8 J/cm2/d
Psychological impact	after delivering a dose of 8 J/cm2/d

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Centre Régional de Cancérologie et Thérapie Cellulaire Pédiatrique, CHU de Clermont-Ferrand; Faculté de chirurgie dentaire, Clermont-Ferrand; Centre de Pharmacologie Clinique, INSERM CIC 501; Laboratoire des Matériaux Inorganiques, ESA CNRS 6002 et ENSCCF, Université Blaise-Pascal, Aubière
• Investigators: Principal Investigator: Etienne Merlin, MD, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Anticipated): July 1, 2010
• Study Completion (Anticipated): July 1, 2010

Study Registration Dates

• First Submitted: November 3, 2009
• First Submitted That Met QC Criteria: November 3, 2009
• First Posted (Estimate): November 4, 2009

Study Record Updates

• Last Update Posted (Estimate): January 19, 2011
• Last Update Submitted That Met QC Criteria: January 18, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Cancer; Children; Prevention; Chemotherapy; Mucositis; Laser; Children with malignancies receiving chemotherapy and/or radiotherapy inducing severe mucositis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: CHU-0060