Clinical trial · Observational
Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No accrual
Summary
Brief summary (as posted)
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
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
| Non-Metastatic Breast Carcinoma | — | UNRESOLVED | — |
| Polyneuropathy; Drug | — | UNRESOLVED | — |
| Polyneuropathy Due to Drugs | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Garmin smartwatch | Device | — | UNRESOLVED |
| REBECCA Mobile application | Other | — | UNRESOLVED |
| REBECCA PC plug-in | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- CIPN group
- description
- Breast cancer patients that developed strong CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
- interventionNames
- Device: Garmin smartwatch
- Other: REBECCA Mobile application
- Other: REBECCA PC plug-in
- label
- No-CIPN group
- description
- Breast cancer patients that developed mild-to-no CIPN symptomatology at post-treatment evaluation (4 weeks after the end of therapy)
- interventionNames
- Device: Garmin smartwatch
- Other: REBECCA Mobile application
- Other: REBECCA PC plug-in
Primary outcomes (4)
- measure
- Correlation of significant deterioration in neurophysiological parameters including alterations in morphology of small fibers or reduced IENFD (Intraepidermal Nerve Fiber Density) on first follow up visit and development of CIPN
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available