Laser for Oral Mucositis in Pediatric Onco-hematology
- Conditions
- Stomatitis
- Interventions
- Device: Laser therapyDevice: Sham therapy
- Registration Number
- NCT02762019
- Lead Sponsor
- IRCCS Burlo Garofolo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laser therapy Laser therapy Children are allocated to receive Laser therapy Sham therapy Sham therapy Children are allocated to receive Sham therapy
- Primary Outcome Measures
Name Time Method Reduction of the grade of oral mucositis 7 days after enrollment 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
- Secondary Outcome Measures
Name Time Method Reduction of pain, age 4-7 years 11 days after enrollment Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R)
Reduction of need for analgesics at day 7 Reduction of the grade of oral mucositis 11 days after enrollment Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the WHO evaluation scale
Reduction of pain, age 8-18 years 11 days after enrollment Reduction of self-reported pain recorded with a numeric rating scale
Adverse events at day 11
Trial Locations
- Locations (8)
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Azienda Ospedaliero universitaria di Parma
🇮🇹Parma, Italy
Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
Spedali civili Ospedale dei Bambini
🇮🇹Brescia, Italy
Ospedale Pediatrico Microcitemico "Antonio Cao"
🇮🇹Cagliari, Italy
Fondazione IRCCS, Policlinico San Matteo
🇮🇹Pavia, Italy
A.O.U. Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
IRCCS Burlo Garofolo
🇮🇹Trieste, Italy