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

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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01007617
• Other study ID #: CHU-0060
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 3, 2009
• Last updated: January 18, 2011
• Start date: June 2009
• Est. completion date: July 2010

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04.73.75.11.95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (5)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucositis scale - World Health Organization (WHO)		after delivering a dose of 2 J/cm2/d	Yes
Secondary	Mucositis period		after delivering a dose of 8 J/cm2/d	Yes
Secondary	Mucositis free survival		after delivering a dose of 8 J/cm2/d	Yes
Secondary	Pain intensity		after delivering a dose of 8 J/cm2/d	Yes
Secondary	Morphinic administration		after delivering a dose of 8 J/cm2/d	Yes
Secondary	Duration of hospitalisation		after delivering a dose of 8 J/cm2/d	Yes
Secondary	Febrile neutropenia		after delivering a dose of 8 J/cm2/d	Yes
Secondary	Duration of parenteral nutrition		after delivering a dose of 8 J/cm2/d	Yes
Secondary	Psychological impact		after delivering a dose of 8 J/cm2/d	Yes