MedTrace Logo

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

NCT01007617 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-01-19

No results posted yet for this study

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.

Conditions

  • Oral Mucositis

Interventions

DEVICE

LLLT :low level laser therapy

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.

Sponsors & Collaborators

  • Centre Régional de Cancérologie et Thérapie Cellulaire Pédiatrique, CHU de Clermont-Ferrand

    collaborator UNKNOWN

  • Faculté de chirurgie dentaire, Clermont-Ferrand

    collaborator UNKNOWN

  • Centre de Pharmacologie Clinique, INSERM CIC 501

    collaborator UNKNOWN

  • Laboratoire des Matériaux Inorganiques, ESA CNRS 6002 et ENSCCF, Université Blaise-Pascal, Aubière

    collaborator UNKNOWN

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Etienne MERLIN, MD · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01007617 on ClinicalTrials.gov