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Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes
Sponsor: Theodoros Foukakis
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
Official title: 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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2024-03-31
Completion Date
2026-12
Last Updated
2025-03-05
Healthy Volunteers
No
Conditions
Interventions
Garmin smartwatch
* 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)
REBECCA Mobile application
* 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)
REBECCA PC plug-in
* 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)
Karolinska University Hospital
Solna, Stockholm County, Sweden