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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50231

Enrollment

Registered

2016-01-15

Start date

2016-07-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral mucositis

Interventions

Patients will be given either divergent Low Level Laser Therapy (dLLLT) or placebo therapy(PT). ) For both treatments the Mellinn650 will be used. For dLLLT the Mellinn650 will be used with clips wi

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Number of days of mucositis > grade 1	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)