Measurement of superficial scalp skin temperature during scalp cooling as applied for prevention of hair loss due to chemotherapy.

For years already scalp cooling is applied during chemotherapy. Unfortunately
it's not succesful with everyone. During scalp cooling with the Paxman cooler
the scalp skin reaches with the present cooling liquid probable a temperature
of 15-20°C . There is a pretty big interindividual spreading. The optimal
temperature of the scalp skin to reach maximum hairprotection is unknown, but
it is likely that maximum hairprotection is reached with more patients when the
cooling liquid in the machine is a few degrees lower than is possible with the
present cooling liquid. Therefore, the manufacturer has recently developed a
new cooling liquid.

The primary goal is to find out whether or not you can reach with the new
cooling liquid in the Paxman cooler, and probably with air cooling, a ±5°C
lower temperature of the scalp skin.
The secundary goal is to find out how a possibly reached lower temperatur of
the scalp skin is being endured. In addition the goal is to find out wether or
not there is a drop in body temperature during scalp cooling.

This will be a pilot study. Ten healthy, voluntary subjects will be collected.
They will be cooled once with the Paxman cooler with the recent cooling liquid,
once with the new cooling liquid and maybe once with air cooling. The cooling
time per session will be 90 minutes. By means of a temperaturemaesurement
developed by the TU Eindhoven the temperature of the scalp skin will be
maesured during the cooling. When the temperature is still decreasing between
60 and 85 minutes(>1°C), then the cooling time will be lengthened to 120
minutes.
The body temperature will be maesured by means of a earthermometer. In addition
the central bodytemperature during cooling with the new liquid will be maesured
at a few subject by means of a "pill". This "pill" is a temperaturesensor which
can be swallowed. After four hours the "pill" is in the small intestine. By
means of maesuring equipment the signals of the "pill" can be received and the
central bodytemperature registered carefully. The "pill" leaves the body later
via the stools. It has nog consequenses for the subject.
On the basis of a earlier clinical applied questionnaire the degree of enduring
per cooling session will be watched.

There are no risks attached to participation and the expectation is that the
degree of enduring will not be high:
At this moment a QoL-study is being performed under patients who are treated
with scalp cooling. The results are yet not analysed and publiced. But it is
known that when patients are asked how they endure cooling with the standard
temperature, they score a 7,6 on a scale from 0-10, in which 0=not to endure
and 10=very good to endure.
With 82%(n=572) of the cooling session no headache is being reported, with
14%(n=98) mild headache, with 3%(n=25) moderate headache and with 1%(n=10)
heavy headache.
It is expected that the duration of the cooling will not be a problem for the
subjects. There are namelijk chemotherapy courses, including Taxol, which have
a entering time of 4 hours. With half an hour of precooling and one and a half
hour of postcoolingtime, these patients are being cooled during 6 hours. Also
the temperature of the cooling cap shouldn't be a problem. The machine has a
constant temperature of -10°C. With this the scalp skin probably gets a
temperature between 15 and 20°C. To get a scalp skin temperature between 10 and
15°C, the new cooling liquid will probably have to get a temperature of -15°C.
In the past cooling is being performed without any problems with cooling caps
from a freezer of -30°C, a substantial lower temperature than the temperature
of the cooling liquid. This cap warmed up slowely indeed, but after every half
hour the cap had to be replaced by a new cap of -30°C.