NCT06052345 Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes
| NCT ID | NCT06052345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Theodoros Foukakis |
| Condition | Breast Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-31 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-03-31 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Theodoros Foukakis, MD, PhD
PRINCIPAL INVESTIGATOR
Karolinska University Hospital
Frequently Asked Questions
Who can join the NCT06052345 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06052345 currently recruiting?
Yes, NCT06052345 is actively recruiting participants. Contact the research team at theodoros.foukakis@ki.se for enrollment information.
Where is the NCT06052345 trial being conducted?
This trial is being conducted at Solna, Sweden.
Who is sponsoring the NCT06052345 clinical trial?
NCT06052345 is sponsored by Theodoros Foukakis. The principal investigator is Theodoros Foukakis, MD, PhD at Karolinska University Hospital. The trial plans to enroll 100 participants.