Clinical trial NCT02762019: Laser for Oral Mucositis in Pediatric Onco-hematology
Official title: LAMPO: Multicenter Randomized Double-blind Controlled Trial to Evaluate the Efficacy of Laser Therapy for Treatment of Oral Mucositis Induced by Chemotherapy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stomatitis
Keywords: Stomatitis
Laser
Children
Chemotherapy
Treatment
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 101
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction of the grade of oral mucositis
timeFrame: 7 days after enrollment
Secondary outcomes:
measure: Reduction of the grade of oral mucositis
timeFrame: 3 days after enrollment
measure: Reduction of the grade of oral mucositis
timeFrame: 11 days after enrollment
measure: Reduction of pain, age 4-7 years
timeFrame: 3 days after enrollment
measure: Reduction of pain, age 8-18 years
timeFrame: 3 days after enrollment
measure: Reduction of pain, age 4-7 years
timeFrame: 7 days after enrollment
measure: Reduction of pain, age 8-18 years
timeFrame: 7 days after enrollment
measure: Reduction of pain, age 4-7 years
timeFrame: 11 days after enrollment
measure: Reduction of pain, age 8-18 years
timeFrame: 11 days after enrollment
measure: Reduction of need for analgesics
timeFrame: at day 7
measure: Adverse events
timeFrame: at day 11
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
city: Brescia
country: Italy
facility: Spedali civili Ospedale dei Bambini
city: Cagliari
country: Italy
facility: Ospedale Pediatrico Microcitemico "Antonio Cao"
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Parma
country: Italy
facility: Azienda Ospedaliero universitaria di Parma
city: Pavia
country: Italy
facility: Fondazione IRCCS, Policlinico San Matteo
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
Study officials:
affiliation: IRCCS Burlo Garofolo, Trieste
name: Giulio Andrea Zanazzo, MD
role: STUDY_CHAIR
affiliation: Azienda Ospedaliero Universitaria "Ospedali Riuniti", Trieste
name: Matteo Biasotto, DDS
role: STUDY_CHAIR
References: