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
Location: See location...
Intervention Type: Other, Device
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Karolinska University Hospital
RECRUITING
Solna
Contact Information
Primary
Theodoros Foukakis, MD,PhD
theodoros.foukakis@ki.se
0736896713
Time Frame
Start Date: 2024-03-31
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
CIPN group
Breast cancer patients that developed strong CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
No-CIPN group
Breast cancer patients that developed mild-to-no CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
Related Therapeutic Areas
Sponsors
Leads: Theodoros Foukakis
Collaborators: Karolinska Institutet, Centre for Research and Technology Hellas (CERTH)

This content was sourced from clinicaltrials.gov