RecruitingNCT06052345

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)

Sponsor

Theodoros Foukakis

Enrollment

100 participants

Start Date

Mar 31, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Breast Neoplasms

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines nerve damage (neuropathy) that can develop as a side effect of paclitaxel chemotherapy in breast cancer patients. Researchers aim to detect nerve damage early, identify who is at greatest risk, and understand how it affects quality of life. **You may be eligible if...** - You are a woman aged 18 or older - You have newly operated, early-stage breast cancer without spread to other organs - You are scheduled to receive paclitaxel-containing chemotherapy after surgery - Your prior chemotherapy was limited to cyclophosphamide and epirubicin - You are in good overall health **You may NOT be eligible if...** - You have previously taken drugs known to cause nerve damage - You have a pre-existing nerve condition or inherited disorder affecting nerves - You have diabetes or impaired blood sugar - You have moderate to severe pre-existing neuropathy symptoms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGarmin 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)

OTHERREBECCA 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)

OTHERREBECCA 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