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

NCT06052345 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-03-05

No results posted yet for this study

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

Conditions

  • Breast Neoplasms
  • Breast Cancer
  • Early-stage Breast Cancer
  • Non-Metastatic Breast Carcinoma
  • Polyneuropathy Due to Drugs
  • Polyneuropathy; Drug
  • Chemotherapy-induced Peripheral Neuropathy
  • Quality of Life

Interventions

DEVICE

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)

OTHER

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)

OTHER

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

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Centre for Research and Technology Hellas (CERTH)

    collaborator UNKNOWN

  • Theodoros Foukakis

    lead OTHER

Principal Investigators

  • Theodoros Foukakis, MD, PhD · Karolinska University Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052345 on ClinicalTrials.gov