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NCT06052345 · ClinicalTrials.gov record · last posted 2026-08-14

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

Study acronym: CIPN-REBECCA
StatusWithdrawn
PhaseNot specified
Started2024-03-31
View on ClinicalTrials.gov ↗
Why the trial stopped
No accrual
from the ClinicalTrials.gov record
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

Protocol amendment history 5 changes detected by DataLookout

2026-08-15
Trial status changed: Recruiting → Withdrawn
2026-08-15
Trial withdrawn: No accrual
2026-08-15
Enrollment reduced: 100 → 0 participants
2026-08-15
Primary completion pushed: 2025-12 → 2025-12-31
2026-08-15
Completion moved earlier: 2026-12 → 2025-12-31
Trial Details
NCT Number NCT06052345
Lead Sponsor Theodoros Foukakis
Collaborators: Karolinska Institutet, Centre for Research and Technology Hellas
Conditions 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
Start Date 2024-03-31
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-14