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| 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 |
| ClinicalTrials.gov Identifier: | NCT01007617 |
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 II Phase III |
| 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" |
| 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) |
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 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Patrick LACARIN | 04.73.75.11.95 | placarin@chu-clermontferrand.fr |
| France | |
| CHU Clermont-Ferrand | Recruiting |
| Clermont-Ferrand, France, 63000 | |
| Contact: Patrick LACARIN 04.73.75.11.95 placarin@chu-clermontferrand.fr | |
| Principal Investigator: | Etienne MERLIN, MD | University Hospital, Clermont-Ferrand |
More Information
| 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 |
|
Children Cancer Mucositis Laser |
Prevention Chemotherapy Children with malignancies receiving chemotherapy and/or radiotherapy inducing severe mucositis |
|
Stomatitis Mucositis Mouth Diseases Stomatognathic Diseases |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |