SarcopeniaNeuro-SarcNCT06996548
Sarcopenia and Paclitaxel-Induced Neuropathy in Early Stage Breast Cancer (Neuro-Sarc)
An observational study of Sarcopenia and Paclitaxel Induced Neuropathy, run by Gazi University at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Sarcopenia, Paclitaxel Induced Neuropathy, Breast Carcinoma
- How many people
- 120 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 6 May 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- No pathological diagnosis of breast cancer
- Refusal to participate in the study
- Male patients
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06170
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Yenimahalle, 06200
Gazi University
Ankara, Yenimahalle, 06560
About this study
Official title: Investigation of the Relationship Between Sarcopenia and Paclitaxel-Induced Neuropathy in Early Stage Breast Cancer Patients (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.
Read the 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
- Medical subject headings
- Sarcopenia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to end of paclitaxel treatment (approximately 12 weeks)
Secondary outcomes (2)
Severity of Chemotherapy-Induced Peripheral Neuropathy
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.
Measured: At the end of paclitaxel treatment (approximately 12 weeks)
Association Between Sarcopenia and Peripheral Neuropathy
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.
Measured: From baseline to end of treatment (approximately 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Nov 2024
- Primary completion6 May 2025
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orhun Akdoğan, Gazi University
- Investigators
- Ilknur Deliktas, MD, Principal investigator, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996548
- Sponsor's protocol ID
- NEURO-SARC-001
- Other IDs
- 2024-10/157
- Acronym
- Neuro-Sarc
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policies and the absence of a data sharing infrastructure. The study involves sensitive clinical information, and no formal mechanism for anonymized data sharing is currently in place.
Publications
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.
PubMed 41238950
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Sarcopenia and Paclitaxel-Induced Neuropathy in Early Stage Breast Cancer Patients (Neuro-Sarc)
- ClinicalTrials.gov ID
- NCT06996548
- Acronym / sponsor ID
- Neuro-Sarc / NEURO-SARC-001
- Conditions
- Sarcopenia, Paclitaxel Induced Neuropathy, Breast Carcinoma
- Keywords
- Paclitaxel, Breast cancer, Sarcopenia, Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Age < 18 years
- No pathological diagnosis of breast cancer
- Refusal to participate in the study
- Male patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Severity of Chemotherapy-Induced Peripheral Neuropathy
Time frame: At the end of paclitaxel treatment (approximately 12 weeks)
Association Between Sarcopenia and Peripheral Neuropathy
Time frame: From baseline to end of treatment (approximately 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Results publication: PubMed 41238950Onur 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policies and the absence of a data sharing infrastructure. The study involves sensitive clinical information, and no formal mechanism for anonymized data sharing is currently in place.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilknur Deliktas, MD principal investigator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Paclitaxel Induced Neuropathy, run by Gazi University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Paclitaxel-Induced Peripheral Neuropathy (time frame: From baseline to end of paclitaxel treatment (approximately 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06996548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.