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

NCT06052345

WithdrawnN/A

Sponsor: Theodoros Foukakis

Conditions: Breast Neoplasms, Breast Cancer, Early-stage Breast Cancer, Non-Metastatic Breast Carcinoma, Polyneuropathy Due to Drugs

Interventions: Garmin smartwatch, REBECCA Mobile application, REBECCA PC plug-in

Countries: Sweden

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (1)

Solna, Stockholm County, Sweden