Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes
Chemotherapy(paclitaxel)-induced Polyneuropathy in Breast Cancer As Part of the REBECCA Project (REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data)
Theodoros Foukakis
100 participants
Mar 31, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria10
- 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
Interventions
* Physical activity (Activity sessions, type and length of activity, activity intensity estimations) * Meal detection and meal characteristics (accelerometry and gyroscope data) * Oxygen saturation (pulse oximetry) * Number of steps (pedometer) * Stress level indicators (based on heart-rate analytics) * Sleep patterns (sleep and wake-up time, sleep quality)
* GPS positioning (daily location change patterns through pathway analysis and Point-of-interest analysis based on type-of-location automatic detection) * Self-reports from patients and companions reports on mental and physical health, as well as periodic quality of life evaluations3 * Patient self-uploaded pictures of meals (for evaluation of nutritional habits) and living environment stressors (for evaluation of living environment and self-perceived stressor analysis)
* the developed plug-in monitors online activity, collecting anonymized data from web-browsers (Chrome) and social media (Facebook, Youtube and Instagram). * These are relevant to current and historical data on: i) keywords in searches, ii) types of websites visited, iii) reactions to posts, iv) participation in online groups, v) types of bookmarked websites
Locations(1)
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NCT06052345