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

• ClinicalTrials.gov Identifier: NCT01007617
• Recruitment Status: Unknown
• First Posted: November 4, 2009
• Last Update Posted: January 19, 2011
• 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
• Information provided by: University Hospital, Clermont-Ferrand

Tracking Information

• First Submitted Date: November 3, 2009
• First Posted Date: November 4, 2009
• Last Update Posted Date: January 19, 2011
• Study Start Date: June 2009
• Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 3, 2009): Mucositis scale - World Health Organization (WHO) [ Time Frame: after delivering a dose of 2 J/cm2/d ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 3, 2009)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Low-energy Laser Therapy for Prevention of Oral Mucositis in Children
• Official Title: Evaluation of Low-energy Laser Therapy for Prevention and Reduction of Severity of Oral Mucositis in Children "Mucositis Laser 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.

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
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Oral Mucositis

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.

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 3, 2009): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2010
• Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01007617
• Other Study ID Numbers: CHU-0060
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
• Study 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

• PRS Account: University Hospital, Clermont-Ferrand
• Verification Date: January 2011