Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes

The patients who follow the inclusion criteria of the study will be asked to complete:

• a baseline evaluation prior to receiving treatment. This will include a bedside clinical-neurological evaluation, nerve conduction studies (NCS) and quantitative sensory tests of thermal threshold (QST), blood sampling, an oral glucose tolerance test, a skin biopsy, and answering of questionnaires for assessment of symptoms of peripheral neuropathy as well as self-reports on their pre-treatment health and lifestyle status and cancer specific symptomatology
• an on-treatment evaluation 4 weeks after the start of the treatment which will include NCS and QST
• a post-treatment evaluation 4 weeks after the end of treatment which will include the evaluations stated above. During this visit the participants will be provided with the REBECCA lifestyle monitoring system which will include a smartwatch, installation of a mobile app and a PC plugin. The patients will be also asked to fill in some self-rated evaluations as in the pre-treatment period. Researchers, based on the outcomes of the participants, will divide them in two study groups A. CIPN-group and B. No CIPN which will be monitored with the REBECCA monitoring system.
• a final evaluation. This will be performed 8 months after the post-treatment evaluation and it will include clinical-neurological evaluation, nerve conduction studies (NCS) and thermal threshold testing (QST). Additionally, the participants will be requested to fill in the same self-rated evaluations as in the baseline and the post-treatment.

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 active HBV or HCV infections
• Have known paraneoplastic syndrome
• Have known alcohol abuse
• Have known pregnancy or nursing