Laser for Oral Mucositis in Pediatric Onco-hematology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-10-31

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.

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Detailed Description

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Conditions

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Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Laser therapy

Children are allocated to receive Laser therapy

Group Type EXPERIMENTAL

Laser therapy

Intervention Type DEVICE

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.

Sham therapy

Children are allocated to receive Sham therapy

Group Type SHAM_COMPARATOR

Sham therapy

Intervention Type DEVICE

Only the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity.

Interventions

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Laser therapy

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.

Intervention Type DEVICE

Sham therapy

Only the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity.

Intervention Type DEVICE

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No