Low-energy Laser Therapy for Prevention of Oral Mucositis in Children
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|ClinicalTrials.gov Identifier: NCT01007617|
Recruitment Status : Unknown
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was: Recruiting
First Posted : November 4, 2009
Last Update Posted : January 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Oral Mucositis||Device: LLLT :low level laser therapy||Phase 2 Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of Low-energy Laser Therapy for Prevention and Reduction of Severity of Oral Mucositis in Children "Mucositis Laser 1"|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||July 2010|
|Estimated Study Completion Date :||July 2010|
- 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.
- Mucositis scale - World Health Organization (WHO) [ Time Frame: after delivering a dose of 2 J/cm2/d ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007617
|Contact: Patrick LACARINfirstname.lastname@example.org|
|Clermont-Ferrand, France, 63000|
|Contact: Patrick LACARIN 04.73.75.11.95 email@example.com|
|Principal Investigator:||Etienne MERLIN, MD||University Hospital, Clermont-Ferrand|