Divergent Low Level Laser Therapy as novel treatment for oral mucositis in pediatric cancer patients

Phase 3

Completed

• Conditions: Oral mucositis; damage of oral mucosa; 10031013

• Registration Number: NL-OMON50231
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
Age 4-18 years (below the age of 4 the device is not feasible due to the size
of the clips).
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 if they meet all of the following criteria:
- Cancer therapy induced oral mucositis > grade 1
- Hospitalized
- Written informed consent

Exclusion Criteria

- Previous participation
- Impossibility to use dLLLT or PLT (e.g. mechanical ventilation)
- Patients and their parents are excluded when they are insufficiently capable
of speaking and understanding the Dutch language

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of days of mucositis > grade 1</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>i. Peak level of mucositis according to the NCI-CTCAE scoring system<br /><br>ii. Peak level of mucositis according to the WHO mucositis system<br /><br>iii. Days of oral pain, measured with VAS or Faces scoring system (age<br /><br>dependent)<br /><br>iv. Peak level of pain, measured with VAS or Faces scoring system (age<br /><br>dependent)<br /><br>v. Use of pain medication;<br /><br>1. Type and dosage of medicine;<br /><br>2. Length of use in days;<br /><br>3. Frequency.<br /><br>vi. Number of infectious complications during hospital stay<br /><br>vii. Quality of life, measured with the Pedsqual questionnaire five days after<br /><br>the start of study treatment<br /><br>viii. Nutritional state (length at start, daily weight)<br /><br>ix. Positive culture not otherwise specified (e.g. throat culture, wound<br /><br>culture)<br /><br>x. Costs<br /><br>xi. Incidence of oral mucositis, according to the Child International<br /><br>Mucositis<br /><br>Evaluation Score (ChIMES)</p><br>