Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes
Recruiting now
Conditions studied: 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
In brief
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
Key facts
- Study ID
- NCT06052345
- Run by
- Theodoros Foukakis
- People needed
- 100
- Starts
- 2024-03-31
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-03-05
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Karolinska University Hospital — Solna, Stockholm County, Sweden (enrolling)
Full record on ClinicalTrials.gov
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