Effect van verwarmde oxaliplatin op acute perifere neuropathie klachten bij patienten die aanvullend of voor een gevorderde of uitgezaaide darmkanker behandeld worden met oxaliplatin houdende chemotherapie.

Rationale:

Despite of the common preventive medication with calcium and magnesium, sixty to seventy percent of the patients treated with oxaliplatin for a colorectal carcinoma will suffer from an acute peripheral neuropathy. These complaints disable patients temporarily and therefore reduce their quality of live during the treatment with chemotherapy.



Objectives:

Main object: Is there a reduction of the acute peripheral neuropathy complaints of patients with advanced or metastatic colorectal cancer due to the infusion of heated oxaliplatin?

Does the quality of life of these patients improve?

Secondary object: The evaluation of the effectivity of the treatment.



Study design:

A pilot study in 15 patients.



Study population:

Patients treated adjuvant or palliative with oxaliplatin for a colon-rectal carcinoma who suffer from an acute peripheral neuropathy after the first treatment in het St. Antonius hospital of Nieuwegein/Utrecht (The Netherlands).



Intervention:

Oxaliplatin will be heated to a temperature of 36 degrees Celsius during the 2-hours infusion period, irrespective the standard prophylaxis with magnesium and calcium.



Main study parameters/endpoints:

Changes in the acute peripheral neuropathy complaints.
Changes in quality of life (cancer related and symptom related) in the period after infusion of heated oxaliplatin in comparison with the period after infusion of oxaliplatin on roomtemperature.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Before entering the study assessment of acute peripheral neuropathy will be carried out on two moments.
If acute peripheral neuropathy is diagnosed, patients will enter the study. During the second, third and fourth cycle of the chemotherapeutical regime the Total Neuropathy Score examination will be carried out on three moments.
If acute peripheral neuropathy is not diagnosed patients will not enter the study.

There is no physical risk or physiological discomfort to expect from the infusion of heated oxaliplatin.

Does heated oxaliplatin reduce the acute peripheral neuropathy complaints in patient with a colorectal carcinoma.

1. Baseline TNS after course one with oxaliplatin;

2. Just before, 48 hours and one week after two courses with heated oxaliplatin and one course with oxaliplatin on room temperature;

3. CEA, CT scans at baseline, 3 and 6 months after start chemotherapy.

Oxaliplatin will be heated to a temperature of 36 degrees celsius during the 2-hours infusion period, irrespective the standard prophylaxis with magnesium and calcium.