Clinical trial · Observational
Sarcopenia and Paclitaxel-Induced Neuropathy in Early Stage Breast Cancer (Neuro-Sarc)
Investigation of the Relationship Between Sarcopenia and Paclitaxel-Induced Neuropathy in Early Stage Breast Cancer Patients (Neuro-Sarc)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective observational study aims to investigate the relationship between sarcopenia and the development of paclitaxel-induced peripheral neuropathy in patients with early-stage breast cancer. The study was conducted between November 1, 2024, and May 6, 2025, across three oncology centers in Turkey. Skeletal muscle index (SMI) was calculated using pre-treatment computed tomography (CT) scans at the third lumbar vertebra (L3) level. Neuropathy assessment was performed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20-item scale (EORTC QLQ-CIPN20) before and after paclitaxel treatment. Patients reporting neuropathy symptoms were referred for electromyography (EMG) to confirm diagnosis, and neuropathy was graded according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). The association between baseline sarcopenia and both the incidence and severity of neuropathy was analyzed. The findings may help identify patients at higher risk of neurotoxicity from paclitaxel-based chemotherapy.
Conditions
Conditions (3)
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Paclitaxel Induced Neuropathy | — | UNRESOLVED | — |
| Sarcopenia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Paclitaxel-Treated Early Stage Breast Cancer Patients
- description
- Patients aged 18 years or older with early-stage breast cancer who received neoadjuvant or adjuvant paclitaxel-based chemotherapy, including paclitaxel plus carboplatin or paclitaxel plus trastuzumab/pertuzumab. Neuropathy was assessed before and after chemotherapy, and skeletal muscle index was measured from baseline CT scans.
Primary outcomes (1)
- measure
- Incidence of Paclitaxel-Induced Peripheral Neuropathy
- timeFrame
- From baseline to end of paclitaxel treatment (approximately 12 weeks)
- description
- The proportion of patients developing chemotherapy-induced peripheral neuropathy (CIPN) during or after paclitaxel treatment. Neuropathy will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20-item scale (EORTC QLQ-CIPN20; score range: 0 to 100, where higher scores indicate worse symptoms). Electromyography (EMG) will be used to confirm clinical diagnosis when needed.
Secondary outcomes (2)
- measure
- Severity of Chemotherapy-Induced Peripheral Neuropathy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Histologically confirmed early-stage breast cancer * Planned to receive neoadjuvant or adjuvant paclitaxel-based chemotherapy * Patients receiving paclitaxel-carboplatin or paclitaxel-trastuzumab-pertuzumab regimens are also eligible * Provided written informed consent Exclusion Criteria: * Age \< 18 years * No pathological diagnosis of breast cancer * Refusal to participate in the study * Male patients
References
Publications (1)
- RESULTOnur ID, Ozdemir PA, Akdogan O, Baskurt K, Kara MI, Kalkan DO, Uyar GC, Sutcuoglu O, Oksuzoglu B, Gurler F, Savran B, Ciledag N, Ates O, Yildiz F. Impact of sarcopenia on paclitaxel-induced peripheral neuropathy in early-stage breast cancer: a prospective observational study (the neuro-sarc study). Support Care Cancer. 2025 Nov 14;33(12):1061. doi: 10.1007/s00520-025-10157-w. PMID 41238950