Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes
Trial Parameters
Brief Summary
This is a single center prospective observational cohort study that aims to: * examine and identify possible risk and susceptibility factors for the incidence and progression of chemotherapy-induced polyneuropathy (CIPN) in female patients primarily operated for early non-metastatic breast cancer who will receive adjuvant chemotherapy containing paclitaxel * test different neurophysiological methods for early detection of CIPN * explore changes that underlie the development of CIPN in relation to clinical presentations, neurophysiological assessment, including measures of small nerve fiber dysfunction, and possible biochemical, metabolic and genetic associations * explore the effects of CIPN in the patient's lifestyle and quality of life for up to 12 months after the initiation of treatment
Eligibility Criteria
Inclusion Criteria: * Female patients * Age of ≥ 18 years * Newly operated primary breast cancer without metastatic disease receiving adjuvant chemotherapy containing paclitaxel * No prior chemotherapy other than cyclophosphamide and epirubicin * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Written informed consent * Able to communicate with investigators, participate in testing and comply with the requirements of the study-protocol Exclusion Criteria: * Have received drugs suspected/known to cause peripheral neuropathy * Have history of acquired or inherited neuropathy or other genetic disease with increased tendency to develop neuropathy * Have known disturbed glucose metabolism, either diabetes mellitus or impaired glucose tolerance * Have moderate to severe kidney, liver, lung or heart disease * Have known symptomatic or other advanced spinal stenosis * Have known autoimmune disease that potentially cause or contribute to neuropathy * Have known HIV or acti