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

NCT ID: NCT06996548

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-05-06

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.

Detailed Description

This multicenter prospective observational study was designed to evaluate whether baseline sarcopenia is associated with the development and severity of peripheral neuropathy in patients receiving paclitaxel as part of neoadjuvant or adjuvant chemotherapy for early-stage breast cancer.

Patients aged 18 years or older with histologically confirmed early-stage breast cancer who received paclitaxel-based treatment (including combinations with carboplatin, trastuzumab, or pertuzumab) were included. Skeletal muscle index (SMI) was calculated from computed tomography (CT) scans at the third lumbar vertebra (L3) level, taken prior to paclitaxel initiation.

Neuropathy was assessed at baseline and after the final paclitaxel cycle using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20-item scale (EORTC QLQ-CIPN20). Patients with symptoms suggestive of neuropathy were referred for electromyography (EMG) confirmation, and neuropathy severity was classified according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).

The primary aim was to evaluate the association between sarcopenia and the occurrence of chemotherapy-induced peripheral neuropathy (CIPN). Secondary outcomes included the relationship between sarcopenia and the severity grade of neuropathy.

This study seeks to provide insights into risk stratification for CIPN and guide supportive care strategies in early-stage breast cancer patients undergoing taxane-based chemotherapy.

Conditions

Sarcopenia; Paclitaxel Induced Neuropathy; Breast Carcinoma

Keywords

Paclitaxel; Breast cancer; Sarcopenia; Neuropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Orhun Akdoğan

Principal Investigator, Specialist in Medical Oncology, Department of Medical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ilknur Deliktas, MD

Role: PRINCIPAL_INVESTIGATOR

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Locations

Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Gazi University

Ankara, Yenimahalle, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 41238950 (View on PubMed)

Other Identifiers

2024-10/157

Identifier Type: OTHER

Identifier Source: secondary_id

NEURO-SARC-001

Identifier Type: -

Identifier Source: org_study_id