Pilotstudy;
The use of Gelclair film in children undergoing chemo and/or radiotherapy to prevent oral mucositis and improve quality of life.

The IHOBA (Immunology, Hematology, Oncology and Auto-Immune diseases) wards at
the WA-KJC (Willem Alexander Children and Childhood department) treats children
with malicious disorders en benign hematological disorders, and sometimes a
stem cell transplantation is necessary. The treatments includes chemotherapy en
sometimes also radiotherapy. Besides hair loss, nausea and vomiting is oral and
gastrointestinal mucositis one of the most common and interactive side effect
of chemo- and/or radiotherapy.

Depending of the kind of malicious disorder, doses en type of chemo and/or
radiotherapy experienced 40 % of the adult patients en more than 60 % of the
pediatric patients de side effect oral or gastrointestinal mucositis.
Mucositis is associated with heavy pain, most off the time is strong pain
medication necessary in the form of opiates. There is weight loss, because of
the reduced oral intake. Sometimes it is necessary to start met tube-feeding,
or parenteral feeding. At last gastrointestinal mucositis leads to diarrhea en
infections of the intestine. This affects the quality off life. Damage of the
mucosal en the cause of ulcers makes that the patient with low resistance
accessible is for translocation of bacteria and viruses, what can cause
life-threatening infections. Patients with oral mucositis and neutropenia are 4
times more at risk for infections than patients without neutropenia. De side
effects can cause reduction of the chemo- and/or radiotherapy, but that has
consequences for the result of the treatment.
Not only clinical disturbances are a consequence of the mucositis, but also
financial burden, because of the higher amount of days in the hospital.

Despite all the effort, there are still no effective prophylaxes or treatment
for oral mucositis. For now the treatment includes good mouth care and pain
control, to reduce the bother of this side effect. Study*s at oral mucositis is
focused on the adult patient in contrast with the fact that oral mucositis is
seen more with the pediatric patients. Completed study*s and the study*s that
are still open are focused on finding a prophylaxes for the oral mucositis, but
they didn*t found a successful treatment yet. Meanwhile the pain and the bad
nutritional state affect the quality of life strongly.
In the United State they use the oral rinse Gelclair when the patient has
disturbances of pain with oral mucositis. There is no research outcome found
about study*s with pediatric patients and Gelclair. Completed study*s are
focused on adult patients with oral mucositis grade 3 or 4.

To study the effect of Gelclair mouth rinse on pain by oral mucositis as a
consequence of chemo- and/or radiotherapy, with pediatric patients. Primary we
look at the WHO gradation of oral mucositis. In second part we also look at the
nutritional state by looking at the weight(loss) en infection parameters, like
fever. We also ask the children on the effect on quality off life.

Every pediatric patient on the IHOBA sub-clinical ward and the IHOB-policlinic
at the WA-KJC, who is diagnosed with oral mucositis grade 1 t/m 4 is asked,
after verbal and by letter approval, to participate on this pilot study. The
patients are asked to use the mouth rinse by prescription. The treatment
includes rinsing with the Gelclair for minimal 3 times a day. Children under
the age of 4 can*t rinse, so for them it is enough to tough the ulcers with the
Gelclair. Next to the use of the Gelclair we ask de parents (and the patients
itself when the are older than 16 years old) to keep up a diary. When the
parents are not able to speak or read the Dutch language, the nurses on the
IHOBA wards are asked to fill in the diary.

The next subjects are looked at:
• mucositis grade by the WHO grading for oral mucositis,. At this point we also
look at the duration and the course of the mucositis
• Pain score. By the pain score there is a distinction between age.
o 0-4 years * pain measurement according the POKIS-scale. The child is shortly,
carefully observed on 7 behavior ratings. The pain score can vary between 0 and
7.
o 4-7 years * pain measurement by self report with the OUCHER-scale. 6 faces
translate a level of pain. The pain score can vary between 0 and 5.
o 7 and older * pain measurement by self report. The patient is ask to descripe
the pain in to a number what is comparable with his pain. The pain score can
vary between 0 and 10.
• Pain medication. Which pain medication is used and in which dose,
• Fever. Temperature is measured 1 times a day in the morning. When the
temperature is above 38,5 *C, the temperature is measured 3 times a day.
• Use of antibiotics. Which antibiotics and which dose.

To get an overall picture we also look at the next subjects:
• Was hospitalization or elongation of the hospitalization necessary in
relation with the oral mucositis?
• Course of weight. Weight is measured at start of the use of Gelclair and
after completing the use of Gelclair.
• Is tube-feeding started in relation with the oral mucositis
• How many times did the patient use the Gelclair, and for how long.
• Did the patient the mouth rinse as a rinse or are the ulcers touched with the
rinse?
We ask the parents to answer these questions at the and of the use of Gelclair

To complete the study we also look at the next subject:
• witch kind of chemotherapy is used, and what was the dose
• did the patient receive radiotherapy, and what was the total dose
• when the patient had any ulcers, Did the nurse took a sample of these ulcer,
to be sure that there was no underlying infection.
The researcher will check these subjects from the patient*s status en will be
analyzed.

The control group does exist of 10 children who are diagnosed with oral
mucositis grade1 t/m 4, in the last 4 months of 2007. This is a retrospective
data collection.

3x day rinse with Gelclair

Mild allergic reaction to gelclair may sporadically occur. These are of minimal
risk to the patient related to the maximal benefit expected.