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

NCT06996548 | Completed

• 2 other identifiers: NEURO-SARC-0012024-10/157
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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; Breast Carcinoma; Paclitaxel Induced Neuropathy

Keywords

Paclitaxel; Breast cancer; Sarcopenia; Neuropathy

Outcome Measures

Primary Outcomes (1)

• Incidence of Paclitaxel-Induced Peripheral Neuropathy

  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.

  From baseline to end of paclitaxel treatment (approximately 12 weeks)

Secondary Outcomes (2)

• Severity of Chemotherapy-Induced Peripheral Neuropathy

  At the end of paclitaxel treatment (approximately 12 weeks)

• Association Between Sarcopenia and Peripheral Neuropathy

  From baseline to end of treatment (approximately 12 weeks)

Study Arms (1)

Paclitaxel-Treated Early Stage Breast Cancer Patients

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Only individuals who self-identify as women and have a biologically female sex assigned at birth are eligible to participate in this study due to the focus on early-stage breast cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of adult female patients diagnosed with early-stage breast cancer and treated with neoadjuvant or adjuvant paclitaxel-based chemotherapy regimens at three oncology centers in Turkey. Patients were enrolled consecutively if they met the inclusion criteria and provided informed consent. Data were collected prospectively, including pre-treatment CT scans for muscle mass analysis and neuropathy assessments.

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• No pathological diagnosis of breast cancer
• Refusal to participate in the study
• Male patients

Sponsors & Collaborators

• Gazi University: lead

Study Sites (3)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Gazi University

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Location

Related Publications (1)

• Onur 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 RESULT

MeSH Terms

Conditions

Sarcopenia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ilknur Deliktas, MD

  Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Specialist in Medical Oncology, Department of Medical Oncology

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: November 1, 2024
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)