Primary Objective: - To assess the effect of divergent LLLT on the number of days of mucositis > grade 1Secondary Objective(s): - To assess the effect of divergent LLLT on the severity of mucositis - To assess the effect of divergent LLLT on the…
ID
Source
Brief title
Condition
- Oral soft tissue conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of days of mucositis > grade 1
Secondary outcome
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)
Background summary
The survival of children with cancer increased extensively in the last decades
due to more intensive treatment protocols consisting of chemotherapy,
radiotherapy and surgery. Unfortunately, these intensive treatments potentially
cause severe treatment related side effects. Oral mucositis (OM) is one of
these potentially severe side effects of chemotherapy and radiotherapy, and can
lead to severe pain, suboptimal feeding, increased risk of infection and a
reduced quality of life. We will study the effect of therapeutic use of
divergent Low Level Laser Therapy(dLLLT) in pediatric patients suffering from
chemotherapy-induced OM in a double-blind randomized placebo-controlled trial.
Study objective
Primary Objective:
- To assess the effect of divergent LLLT on the number of days of mucositis >
grade 1
Secondary Objective(s):
- To assess the effect of divergent LLLT on the severity of mucositis
- To assess the effect of divergent LLLT on the number of infections
- To assess the effect of divergent LLLT on the quality of life
- To assess the incidence of mucositisin children treated with cancer
Study design
Double-blind randomized placebo controlled trial
Intervention
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 with laser light (laser and prism
situated in the clips). For PT the Mellinn650 will be used with clips that do
not emit light (laser is internally disconnected).
Study burden and risks
Included patients will either receive dLLLT or placebo therapy (PT). All
pediatric patients with cancer therapy induced oral mucositis will benefit from
this study in the future, since the results, either positive or negative, of
this study will be implemented in the clinic after the study is finished. The
burden of the patient is minimal, since no extra diagnostic procedures will be
done and dLLLT therapy is non-invasive. The patient has to fill in a diary
daily. And the patient has to fill in a quality of life questionnaire ones.
LLLT has no reported or theoretical serious adverse effects or side effects
beyond those reported for PT. Therefore there are no risks associated with the
study other than the risks the study patients already have due to their illness
and therapy, thus being prone to severe infections.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50630.042.15 |