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

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.

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Key information

Conditions

Sarcopenia Atrophy Breast Carcinoma Breast Diseases Breast Neoplasms Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paclitaxel Induced Neuropathy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Etlik City Hospital, Ankara, Yenimahalle, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Incidence of Paclitaxel-Induced Peripheral Neuropathy

Time frame: 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 outcomes

Severity of Chemotherapy-Induced Peripheral Neuropathy

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Investigation of the Relationship Between Sarcopenia and Paclitaxel-Induced Neuropathy in Early Stage Breast Cancer Patients (Neuro-Sarc)

Acronym: Neuro-Sarc

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: May 30, 2025
Registry last updated: Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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