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

NCT01007617 | Unknown Phase 2

• 1 other identifier: CHU-0060
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Keywords

Children; Cancer; Mucositis; Laser; Prevention; Chemotherapy; Children with malignancies receiving chemotherapy and/or radiotherapy inducing severe mucositis

Outcome Measures

Primary Outcomes (1)

• Mucositis scale - World Health Organization (WHO)

  after delivering a dose of 2 J/cm2/d

Secondary Outcomes (8)

• 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

Interventions

LLLT :low level laser therapy DEVICE

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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
• Absence of consent lit by parents or child

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Centre Régional de Cancérologie et Thérapie Cellulaire Pédiatrique, CHU de Clermont-Ferrand: collaborator
• Faculté de chirurgie dentaire, Clermont-Ferrand: collaborator
• Centre de Pharmacologie Clinique, INSERM CIC 501: collaborator
• Laboratoire des Matériaux Inorganiques, ESA CNRS 6002 et ENSCCF, Université Blaise-Pascal, Aubière: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Stomatitis; Neoplasms; Mucositis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Etienne MERLIN, MD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04.73.75.11.95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 19, 2011

Record last verified: 2011-01

Locations

FR (1)