Children, Cancer, Oral Mucositis, Low Level Laser Therapy. Kinderen, kanker, orale mucositis
Conditions
Interventions
Shorty after diagnosis of the patient, at least 14 days before mucositis possibly occurs, the investigator will inform the patient and / or the parents/caretakers about this study with oral and writte
Sponsors
University Medical Center Groningen (UMCG), Beatrix Children's Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Age 4-18 years (below the age of 4 years the device is not feasible due to the size of the clips). Written informed consent Diagnosed with a haematological malignancy or solid tumor, or scheduled for hematopoietic stem cell transplantation. Treatment with chemotherapy possibly causing oral mucositis. Patients will only be randomized to receive either dLLLT or Placebo Therayp (PT) if they meet all of the following criteria: - Chemotherapy-induced oral mucositis > grade 1 - Hospitalized
Exclusion criteria
Exclusion criteria: - Previous participation - Impossibility to use dLLLT or PT (e.g. mechanical ventilation) - Patients and their parents are excluded when they are insufficiently capable of speaking and understanding the Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days of mucositis > grade 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Peak level of mucositis according to the NCI-CTCAE scoring system - Days of oral pain - Peak level of pain - Use of pain medication(type, dosage, length, frequency) - number of infectious complications - quality of life - nutritional status - positive culture not otherwise specified - costs - incidence of oral mucositis | — |
Contacts
Public ContactW.J.E. Tissing
Pediatric Oncologist and Hematologist Hanzeplein 1
Outcome results
None listed