Laser for Oral Mucositis in Pediatric Onco-hematology (LAMPO)

IRCCS Burlo Garofolo

Status and phase: Completed; Phase 3

Conditions: Stomatitis

Treatments: Device: Sham therapy; Device: Laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02762019

RC 33/12

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 2 patient groups

Laser therapy

Experimental group

Description:

Children are allocated to receive Laser therapy

Treatment:

Device: Laser therapy

Sham therapy

Sham Comparator group

Description:

Children are allocated to receive Sham therapy

Treatment:

Device: Sham therapy