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Sarcopenia and Paclitaxel-Induced Neuropathy in Early Stage Breast Cancer (Neuro-Sarc)

NCT06996548 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-12-29

No results posted yet for this study

Summary

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

  • Sarcopenia
  • Paclitaxel Induced Neuropathy
  • Breast Carcinoma

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Principal Investigators

  • Ilknur Deliktas, MD · Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-05-06
Completion
2025-05-06

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06996548 on ClinicalTrials.gov