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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
101
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.
Only the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity.
Policlinico Sant'Orsola Malpighi
Bologna, Italy
Spedali civili Ospedale dei Bambini
Brescia, Italy
Ospedale Pediatrico Microcitemico "Antonio Cao"
Cagliari, Italy
Azienda Ospedaliera di Padova
Padua, Italy
Azienda Ospedaliero universitaria di Parma
Parma, 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
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
Time frame: 7 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
Time frame: 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
Time frame: 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)
Time frame: 3 days after enrollment
Reduction of pain, age 8-18 years
Reduction of self-reported pain recorded with a numeric rating scale
Time frame: 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)
Time frame: 7 days after enrollment
Reduction of pain, age 8-18 years
Reduction of self-reported pain recorded with a numeric rating scale
Time frame: 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)
Time frame: 11 days after enrollment
Reduction of pain, age 8-18 years
Reduction of self-reported pain recorded with a numeric rating scale
Time frame: 11 days after enrollment
Reduction of need for analgesics
Time frame: at day 7
Adverse events
Time frame: at day 11
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