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

Completed

• Conditions: Sarcopenia; Paclitaxel Induced Neuropathy; Breast Carcinoma

• Registration Number: NCT06996548
• Lead Sponsor: Gazi University

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.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-05
• Primary Completion: 2025-05-06
• Study Completion: 2025-05-06
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Submitted: 2025-06-01
• Last Update Posted: 2025-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Paclitaxel-Induced Peripheral Neuropathy	From baseline to end of paclitaxel treatment (approximately 12 weeks)	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 Outcome Measures

Name	Time	Method
Severity of Chemotherapy-Induced Peripheral Neuropathy	At the end of paclitaxel treatment (approximately 12 weeks)	Neuropathy severity will be graded using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0), ranging from Grade 1 (mild) to Grade 4 (disabling). The correlation between baseline sarcopenia status and the highest grade of neuropathy observed will be evaluated.
Association Between Sarcopenia and Peripheral Neuropathy	From baseline to end of treatment (approximately 12 weeks)	The study will evaluate whether sarcopenia (defined by skeletal muscle index \[SMI\] measured on pre-treatment computed tomography \[CT\] scans) is correlated with the incidence and severity of paclitaxel-induced peripheral neuropathy (CIPN), as determined by EORTC QLQ-CIPN20 scores and CTCAE v4.0 grades.

Trial Locations

Locations (3)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey

Gazi University; 🇹🇷 Ankara, Yenimahalle, Turkey