nerve damage / neuropathy nerve damage
Conditions
Interventions
Hilotherapy is given by using the Hilotherm Chemocare device from BeMedico
(2022). By applying Hilotherapy at 10°C, the hands and feet are continuously
cooled, which locally slows down the metabolis
patients with the same
treatment in the control group receive no intervention that could reduce CIPN
or nail toxicity.
Sponsors
Meander Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Pathology confirmed diagnosed breastcancer Curative treatment Intended treatment with Adriamycine/Doxorubicine (AC) and Paclitaxel or AC dose dense and Paclitaxel Adults (18 years and older)
Exclusion criteria
Exclusion criteria: Simultaneous presence of other malignities Previous treatment with chemotherapy Diagnosed with the Syndrome of Raynaud Rheumatoid complaints before treatment with AC (dd) Paclitaxel Any form of arterial disease, because this is a contra-indication for the use of the Hilotherm Pronounced sensory disturbances Trophic tissue injuries Insufficient knowledge or understanding of the Dutch language Presence of neuropathy symptoms before the start with chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is % of patients with CIPN after twelve cycles. The difference on this outcome measure will be tested with a Chi square test. | — |
Secondary
| Measure | Time frame |
|---|---|
| The primary outcome measure is % of patients with CIPN after twelve cycles. The difference on this outcome measure will be tested with a Chi square test. Also before the start of Paclitaxel courses, before courses 3, 6 and 9 and after courses 12 and 3 and 6 months after completion of the courses of Paclitaxel, the outcome measures are tested with a Chi square test. The difference on the co-primary outcome measure of % patients with grade 2 nail toxicity will also be tested with a Chi-squared test before starting courses, for courses 3,6,9,12 and 3 and 6 months after completion of courses. The difference in percentage of patients with dose changes will be tested with a chi-square test, if the primary outcome measure is statistically significantly less common in the patients in the intervention group. The patients' quality of life is assessed with a t-test for normally distributed outcomes, and with a Wilcoxon Rank sum test if the quality of life scores are not normally distributed. The normality of the distribution is evaluated using the Kolmogorov-Smirnov test. Is there a connection between the expression of GG genotype (rs879207) and the development of CIPN complaints in patients with breast carcinoma treated with Paclitaxel? Exploratory Is there a difference in the effect of hilotherapy when expressing the GG genotype (rs879207) on CIPN complaints in patients with breast cancer treated with Paclitaxel? | — |
Countries
Netherlands
Contacts
Public ContactEJ Veluw
Meander Medisch Centrum
Outcome results
None listed