The effect of hilotherapy on chemotherapy-induced peripheral neuropathy in the treatment of breast cancer with Paclitaxel.
Recruiting
- Conditions
- nerve damage / neuropathy1000629110034606
- Registration Number
- NL-OMON56250
- Lead Sponsor
- Meander Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 162
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is % of patients with CIPN after twelve cycles. The<br /><br>difference on this outcome measure will be tested with a Chi square test. </p><br>
- Secondary Outcome Measures
Name Time Method