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

University Hospital, Clermont-Ferrand

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Oral Mucositis

Treatments

Device: LLLT :low level laser therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01007617

CHU-0060

Details and patient eligibility

About

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.

Full 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

Enrollment

40 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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