Stomatitis
Conditions
Keywords
Stomatitis, Laser, Children, Chemotherapy, 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.
Interventions
DEVICELaser 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.
DEVICESham therapy
Only the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity.
Sponsors
IRCCS Burlo Garofolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Reduction of the grade of oral mucositis | 3 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 4-7 years | 3 days after enrollment | Reduction of self-reported pain recorded with the Faces Pain Scale-Revised (FPS-R) |
| Reduction of pain, age 8-18 years | 3 days after enrollment | Reduction of self-reported pain recorded with a numeric rating scale |
| Reduction of need for analgesics | at day 7 | — |
| Adverse events | at day 11 | — |
Countries
Italy
Outcome results
None listed