Laser for Oral Mucositis in Pediatric Onco-hematology

Study Overview
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Brief Summary
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Children with cancer undergoing intensive chemotherapy (CT) regimens experience many side effects among which oral mucositis (OM) is one of the most debilitating. Modifications of CT's schedule and prolonged hospitalization may be necessary in presence of OM, causing poor general conditions and debilitation. Moreover, the use of narcotic analgesics and total parenteral nutrition may be required, triggering not only a physical deficit but also an economic burden. Despite the frequency and impact of OM among children with cancer, there is no consensus on standard therapy for this condition. Previous studies demonstrated that high power laser therapy can help the maintenance of nutritional status in patients with OM and can remarkably reduce costs/resources needed. Laser therapy has evidence of efficacy in reducing symptoms and in preventing the onset of OM in adult cancer patients but only one randomized controlled trial, with a limited number of children enrolled, supports its use in children for treatment of OM induced by chemotherapy. This multicenter double-blind randomized controlled trial evaluates the efficacy of laser for treatment of oral mucositis secondary to chemotherapy in children aged 3-17 years. The study involves 8 italian hospitals.

Official Title
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LAMPO: Multicenter Randomized Double-blind Controlled Trial to Evaluate the Efficacy of Laser Therapy for Treatment of Oral Mucositis Induced by Chemotherapy in Children

Conditions
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Stomatitis

Intervention / Treatment
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* Device: Laser therapy
* Device: Sham therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 3-18 years Oral mucositis of grade 3 or 4 at enrollment (CTC - WHO scale) Antiblastic chemotherapy in the in the previous three weeks Willingness to undergo treatment for 4 consecutive days and to return for evaluation 7 and 11 days after enrollment. Exclusion Criteria: Previous treatment with laser therapy for stomatitis Presence of dysplastic oral lesions Reduction of mouth opening (<1 cm) Localized head and/or neck radiation treatment in the previous 4 weeks Use of keratinocyte growth factor (KGF) Previous enrollment in the study

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser therapy<br>Children are allocated to receive Laser therapy | Device: Laser therapy<br>* Treatment with K-Laser Cube3 during 4 consecutive days, with the following protocol: 660-970 nm wavelength, 3,2W mean power (6.4W pulsating at 50%), 3'51'' duration, 1-20000 Hz frequency, and 1 cm2 spot size. Laser application was performed all over the oral cavity.<br>|
| Sham Comparator: Sham therapy<br>Children are allocated to receive Sham therapy | Device: Sham therapy<br>* Only the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the grade of oral mucositis | Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the World Health Organization (WHO) evaluation scale | 7 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of the grade of oral mucositis | Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the WHO evaluation scale | 3 days after enrollment | 
| Reduction of the grade of oral mucositis | Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the WHO evaluation scale | 11 days after enrollment | 
| Reduction of pain, age 4-7 years | Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R) | 3 days after enrollment | 
| Reduction of pain, age 8-18 years | Reduction of self-reported pain recorded with a numeric rating scale | 3 days after enrollment | 
| Reduction of pain, age 4-7 years | Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R) | 7 days after enrollment | 
| Reduction of pain, age 8-18 years | Reduction of self-reported pain recorded with a numeric rating scale | 7 days after enrollment | 
| Reduction of pain, age 4-7 years | Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R) | 11 days after enrollment | 
| Reduction of pain, age 8-18 years | Reduction of self-reported pain recorded with a numeric rating scale | 11 days after enrollment | 
| Reduction of need for analgesics |  | at day 7 | 
| Adverse events |  | at day 11 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomatitis, Laser, Children, Chemotherapy, Treatment