Status:
RECRUITING
Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes
Lead Sponsor:
Theodoros Foukakis
Collaborating Sponsors:
Karolinska Institutet
Centre for Research and Technology Hellas (CERTH)
Conditions:
Breast Neoplasms
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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 ...
Detailed 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 evaluati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Have received drugs suspected/known to cause peripheral neuropathy
- Have history of acquired or inherited neuropathy or other genetic disease with increased tendency to develop neuropathy
- Have known disturbed glucose metabolism, either diabetes mellitus or impaired glucose tolerance
- Have moderate to severe kidney, liver, lung or heart disease
- Have known symptomatic or other advanced spinal stenosis
- Have known autoimmune disease that potentially cause or contribute to neuropathy
- Have known HIV or active HBV or HCV infections
- Have known paraneoplastic syndrome
- Have known alcohol abuse
- Have known pregnancy or nursing
Key Trial Info
Start Date :
March 31 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06052345
Start Date
March 31 2024
End Date
December 1 2026
Last Update
March 5 2025
Active Locations (1)
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1
Karolinska University Hospital
Solna, Stockholm County, Sweden, 171 76