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

Breast Cancer Clinical Trial

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)

Status Recruiting

Clinical Trial 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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy-induced Peripheral Neuropathy
• Early-stage Breast Cancer
• Non-Metastatic Breast Carcinoma
• Peripheral Nervous System Diseases
• Polyneuropathies
• Quality of Life

• NCT number: NCT06052345
• Study type: Observational
• Source: Karolinska University Hospital
• Contact: Theodoros Foukakis, MD,PhD
• Phone: 0736896713
• Email: theodoros.foukakis@ki.se
• Status: Recruiting
• Start date: March 31, 2024
• Completion date: September 2025