Stomatitis Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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