Clinical trial NCT06996548: Sarcopenia and Paclitaxel-Induced Neuropathy in Early Stage Breast Cancer (Neuro-Sarc)
Official title: Investigation of the Relationship Between Sarcopenia and Paclitaxel-Induced Neuropathy in Early Stage Breast Cancer Patients (Neuro-Sarc)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Paclitaxel Induced Neuropathy
Breast Carcinoma
Keywords: Paclitaxel
Breast cancer
Sarcopenia
Neuropathy
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Incidence of Paclitaxel-Induced Peripheral Neuropathy
timeFrame: From baseline to end of paclitaxel treatment (approximately 12 weeks)
Secondary outcomes:
measure: Severity of Chemotherapy-Induced Peripheral Neuropathy
timeFrame: At the end of paclitaxel treatment (approximately 12 weeks)
measure: Association Between Sarcopenia and Peripheral Neuropathy
timeFrame: From baseline to end of treatment (approximately 12 weeks)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Yenimahalle
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
state: Yenimahalle
city: Ankara
country: Turkey
facility: Gazi University
state: Yenimahalle
Study officials:
affiliation: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
name: Ilknur Deliktas, MD
role: PRINCIPAL_INVESTIGATOR
References: