A Phase 3 interventional study of Laser therapy and Sham therapy in Stomatitis, sponsored by IRCCS Burlo Garofolo. Completed at 8 sites in Italy. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-05-04.
Sponsored by IRCCS Burlo Garofolo · Phase 3, Interventional, and Treatment
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.
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's enrollment of 101 is above the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →IRCCS Burlo Garofolo is the lead sponsor of 87 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Children are allocated to receive Laser therapy
Device: Laser therapy
Children are allocated to receive Sham therapy
Device: Sham 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.
Only the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity.
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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IRCCS Burlo Garofolo