nerve damage peripheral neuropathy
Conditions
Interventions
One group does not receive hand/foot cooling, one group receives controlled
hand/foot cooling
Sponsors
Tergooiziekenhuizen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Treatment with oxaliplatin
Exclusion criteria
Exclusion criteria: Presence of neuropathie before start treatment oxaliplatin; previous chemotherapy treatment; palliative treatment of pancreas-, oesophagus- or stomachcarcinoma; patients with a life expectancy less than 12 months; Raynaud's phenomenon; Cold-related conditions, including cryoglobulinemia, cold hemagglutination and cold urticaria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in average relative dose intensity (expressed as a percentage of the starting dose) of oxaliplatin in the control group compared to the intervention group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The scores of CIPN and EORTC QLQ-C30 scores are assessed for normality by visually checking the difference scores with a histogram, and testing whether the difference scores are normally distributed with the Shapiro-Wilk test. If the data are normally distributed, the scores are compared with an unpaired t-test. If the data are not normally distributed, the Mann-Whitney test is used. | — |
Countries
Netherlands
Outcome results
None listed