Decreasing acute peripheral neuropathy in patients treated with Oxaliplatin
(heated oxaliplatin versus oxaliplatin on room temperature)

Rationale:
Forty percent of the patients who will be treated with oxaliplatin for a
colo-rectal carcinoma will suffer from an acute peripheral neuropathy, in
spite of the preventive medication. This study wants to answer the question if
warming up oxaliplatin gives a relief of these complaints of patients.

Objective:
Main object
Does warming of oxaliplatin, during the two hours infusion period, reduces the
acute peripheral neuropathy complaints of patients with a colo-rectal tumor
more than 50% in comparison with the standard treatment?
Secondary objects
Is there a difference in severity of acute peripheral neuropathy and quality of
life between the intervention and the standard group of patients?
Is there a correlation between the severity of acute peripheral neuropathy and
the quality of life in both groups?

Study design:
A randomised blinded Clinical Trial, blinded for the nurses who carry out the
neurologic examinations and for those who carry out the analysis.

Intervention:
Patients in the intervention group (arm A) receive warmed oxaliplatin, during a
2-hours infusion (temperature of 360 Celsius), patients in the control group
(arm B) receive oxaliplatin, during a 2-hours infusion (room temperature) and
receive the usual care which exists out of warm packages when patients suffer
from cramps or pain in the infusion arm, if necessary the infusion time will be
prolonged to 6 hours.

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
Patients will undergo a neurologic examination (TNSc) just before (T0), within
24-48 hours (T1) and 7 days (T2) after two infusions of oxaliplatin. The
examination on T0 will take place in the hospital just before the infusion. The
examination on T1 and T2 will take place at the patients home by the trained
nurse to minimize the burden.
Patients will register their experienced peripheral neuropathy complaints and
quality of life by the QlQ30 and QlQ-CIPN20 questionnaire on T0 and T2.

There is no physical risk or physiological discomfort to expect from the
infusion of warmed oxaliplatin. Oxaliplatin will stay stabile if it is warmed
to 41o Celsius, so this intervention will not interfere with the treatment
results.