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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
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
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01007617
First received: November 3, 2009
Last updated: January 18, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Oral Mucositis
Device: LLLT :low level laser therapy
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Mucositis scale - World Health Organization (WHO) [ Time Frame: after delivering a dose of 2 J/cm2/d ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mucositis period [ Time Frame: after delivering a dose of 8 J/cm2/d ] [ Designated as safety issue: Yes ]
  • Mucositis free survival [ Time Frame: after delivering a dose of 8 J/cm2/d ] [ Designated as safety issue: Yes ]
  • Pain intensity [ Time Frame: after delivering a dose of 8 J/cm2/d ] [ Designated as safety issue: Yes ]
  • Morphinic administration [ Time Frame: after delivering a dose of 8 J/cm2/d ] [ Designated as safety issue: Yes ]
  • Duration of hospitalisation [ Time Frame: after delivering a dose of 8 J/cm2/d ] [ Designated as safety issue: Yes ]
  • Febrile neutropenia [ Time Frame: after delivering a dose of 8 J/cm2/d ] [ Designated as safety issue: Yes ]
  • Duration of parenteral nutrition [ Time Frame: after delivering a dose of 8 J/cm2/d ] [ Designated as safety issue: Yes ]
  • Psychological impact [ Time Frame: after delivering a dose of 8 J/cm2/d ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007617

Contacts
Contact: Patrick LACARIN 04.73.75.11.95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Patrick LACARIN    04.73.75.11.95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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
  More Information

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01007617     History of Changes
Other Study ID Numbers: CHU-0060
Study First Received: November 3, 2009
Last Updated: January 18, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Children
Cancer
Mucositis
Laser
Prevention
Chemotherapy
Children with malignancies receiving chemotherapy and/or radiotherapy inducing severe mucositis

Additional relevant MeSH terms:
Stomatitis
Mucositis
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 24, 2014