Chemotherapy-induced Peripheral NeuropathyNCT07048431
Tibial Nerve Elastography in Chemotherapy-Induced Neuropathic Pain
An observational study of Chemotherapy-induced Peripheral Neuropathy and Tibial Neuropathy, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to evaluate the tibial nerve stiffness using Shear Wave Elastography (SWE) in patients with chemotherapy-induced peripheral neuropathy (CIPN) compared to healthy volunteers. A total of 25 patients with a DN4 score ≥4 and 25 healthy controls will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Tibial Neuropathy
- What is being tested?
- Shear Wave Elastography Measurement
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 15 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study included adults aged 18-75 years, divided into two groups: 25 patients with chemotherapy-induced peripheral neuropathy (CIPN) and DN4 scores ≥4, and 25 healthy controls without neuropathy symptoms. All participants underwent clinical screening and were anatomically suitable for tibial nerve ultrasound and shear wave elastography (SWE). Both tibial nerves were evaluated in each subject. Individuals with diabetes mellitus, alcohol use, genetic or toxic neuropathies, systemic diseases, lower limb trauma or lesions, or cognitive/psychiatric disorders affecting cooperation were excluded. The goal was to ensure a homogeneous population for accurate elastographic comparison.
Who may be able to join
- Age between 18 and 75 years
- DN4 score ≥4
- Anatomical suitability for tibial nerve ultrasound and SWE assessment
- Providing written informed consent
Who cannot join
- Presence of diabetes mellitus
- Alcohol use
- Polyneuropathy due to genetic or toxic causes
- Fracture, skin lesion, or edema in the lower extremity
- Severe systemic diseases (e.g., liver, kidney, heart, or lung)
- Inability to visualize the tibial nerve anatomically
- Cognitive or psychiatric disorders preventing cooperation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Etlik, 06000
About this study
Official title: Evaluation of Chemotherapy-Induced Neuropathic Pain Using Shear Wave Elastography Measurements of the Tibial Nerve
This observational study aims to evaluate the tibial nerve stiffness using Shear Wave Elastography (SWE) in patients with chemotherapy-induced peripheral neuropathy (CIPN) compared to healthy volunteers. A total of 25 patients with a DN4 score ≥4 and 25 healthy controls will be assessed. Parameters including nerve diameter, cross-sectional area, depth, and shear wave velocity (V value) will be measured. Demographic and clinical data such as age, gender, chemotherapy protocol, duration, comorbidities, and medications will also be collected. The goal is to investigate SWE as a non-invasive diagnostic tool for CIPN by identifying differences in nerve elasticity between groups.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting side effect observed in 30-40% of patients receiving neurotoxic chemotherapy. CIPN typically presents with sensory symptoms such as paresthesia, numbness, balance disturbances, heightened pain sensitivity, and deep tendon reflex loss. The severity and progression of neuropathy vary widely among patients.
The diagnosis of peripheral neuropathy is based on clinical symptoms and is often supported by nerve conduction studies such as electromyography (EMG). However, EMG can be time-consuming and may be insufficient in advanced cases due to loss of nerve action potentials. Furthermore, subclinical cases of neuropathy may go undetected by EMG.
Recent evidence suggests that pathophysiological changes in CIPN may lead to increased nerve stiffness. Shear Wave Elastography (SWE), a non-invasive ultrasound-based technique, allows for quantitative evaluation of tissue elasticity by measuring shear wave velocity (V value in m/s) and calculating stiffness (E value in kPa). Unlike strain elastography, SWE does not require manual compression, making it more objective and reproducible.
This observational, case-control study aims to assess tibial nerve elasticity using SWE in patients diagnosed with CIPN and to compare the findings with healthy controls. A total of 25 patients with CIPN (defined as a DN4 score ≥4) and 25 age-matched healthy volunteers without neuropathy symptoms will be included. All participants will undergo ultrasound and SWE measurements of bilateral tibial nerve.
Parameters recorded will include the anteroposterior and lateral-medial diameter, cross-sectional area, distance from the skin, and the mean shear wave velocity (V value) obtained from three repeated measurements. In addition, demographic and clinical data such as age, gender, chemotherapy protocol and duration, comorbidities, and current medications will be collected.
The primary objective is to investigate whether tibial nerve elasticity differs significantly between CIPN patients and healthy individuals. This study aims to explore SWE as a potential supportive diagnostic tool for early detection or monitoring of CIPN.
- Being tested
- Shear Wave Elastography Measurement
- Keywords
- Chemotherapy-induced Peripheral Neuropathy, Tibial Neuropathy
- Medical subject headings
- Tibial Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear Wave Elastography MeasurementDiagnostic test
It is a non-invasive imaging technique used to evaluate tissue stiffness. This method involves the use of ultrasound-based shear wave elastography to assess bilateral tibial nerve, by measuring the speed of shear wave propagation through the tissue. Stiffness values are expressed in kilopascals (kPa).
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy-Induced Tibial Neuropathy Group | This group includes adult patients diagnosed with peripheral tibial neuropathy attributed to chemotherapy treatment. Participants must exhibit clinical signs or symptoms consistent with tibial nerve involvement, such as distal lower limb pain, paresthesia, weakness, or altered sensation in the tibial nerve distribution. Receives: Diagnostic Test: Shear Wave Elastography Measurement | |
| Healthy Volunteers Group | This group consists of adult participants with no known acute or chronic medical conditions, neurological disorders, or history of chemotherapy or neurotoxic drug exposure. Individuals must be in good general health, as determined by medical history, physical examination. This group serves as a control population to establish baseline measurements. Receives: Diagnostic Test: Shear Wave Elastography Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear Wave Elastography (SWE) Stiffness Value
Shear Wave Elastography (SWE) is an imaging technique used to quantify tissue stiffness by measuring the propagation speed (V, m/s) of shear waves and converting it into elasticity values (E, kilopascals, kPa). Higher values may indicate fibrosis or increased tension, while lower values may reflect fatty infiltration or atrophy. In peripheral nerves, SWE has been used to assess elasticity in neuropathic conditions. Research shows that affected nerves in neuropathy exhibit increased stiffness compared to healthy nerves. Both shear wave velocity (V) and elasticity modulus (E) can be measured, offering objective, quantitative data to detect and monitor structural nerve changes.
Measured: Single SWE measurement performed within the first week of study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Turan, MD, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048431
- Sponsor's protocol ID
- Tibial Nerve Elastography
- Status last verified
- Jul 2025
- First submitted
- 21 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chemotherapy-Induced Neuropathic Pain Using Shear Wave Elastography Measurements of the Tibial Nerve
- ClinicalTrials.gov ID
- NCT07048431
- Acronym / sponsor ID
- Tibial Nerve Elastography
- Keywords
- Chemotherapy-induced Peripheral Neuropathy, Tibial Neuropathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 2 Jul 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 observational study aims to evaluate the tibial nerve stiffness using Shear Wave Elastography (SWE) in patients with chemotherapy-induced peripheral neuropathy (CIPN) compared to healthy volunteers. A total of 25 patients with a DN4 score ≥4 and 25 healthy controls will be assessed. Parameters including nerve diameter, cross-sectional area, depth, and shear wave velocity (V value) will be measured. Demographic and clinical data such as age, gender, chemotherapy protocol, duration, comorbidities, and medications will also be collected. The goal is to investigate SWE as a non-invasive diagnostic tool for CIPN by identifying differences in nerve elasticity between groups.
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting side effect observed in 30-40% of patients receiving neurotoxic chemotherapy. CIPN typically presents with sensory symptoms such as paresthesia, numbness, balance disturbances, heightened pain sensitivity, and deep tendon reflex loss. The severity and progression of neuropathy vary widely among patients.
The diagnosis of peripheral neuropathy is based on clinical symptoms and is often supported by nerve conduction studies such as electromyography (EMG). However, EMG can be time-consuming and may be insufficient in advanced cases due to loss of nerve action potentials. Furthermore, subclinical cases of neuropathy may go undetected by EMG.
Recent evidence suggests that pathophysiological changes in CIPN may lead to increased nerve stiffness. Shear Wave Elastography (SWE), a non-invasive ultrasound-based technique, allows for quantitative evaluation of tissue elasticity by measuring shear wave velocity (V value in m/s) and calculating stiffness (E value in kPa). Unlike strain elastography, SWE does not require manual compression, making it more objective and reproducible.
This observational, case-control study aims to assess tibial nerve elasticity using SWE in patients diagnosed with CIPN and to compare the findings with healthy controls. A total of 25 patients with CIPN (defined as a DN4 score ≥4) and 25 age-matched healthy volunteers without neuropathy symptoms will be included. All participants will undergo ultrasound and SWE measurements of bilateral tibial nerve.
Parameters recorded will include the anteroposterior and lateral-medial diameter, cross-sectional area, distance from the skin, and the mean shear wave velocity (V value) obtained from three repeated measurements. In addition, demographic and clinical data such as age, gender, chemotherapy protocol and duration, comorbidities, and current medications will be collected.
The primary objective is to investigate whether tibial nerve elasticity differs significantly between CIPN patients and healthy individuals. This study aims to explore SWE as a potential supportive diagnostic tool for early detection or monitoring of CIPN.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy-Induced Tibial Neuropathy Group | – | Diagnostic Test: Shear Wave Elastography MeasurementThis group includes adult patients diagnosed with peripheral tibial neuropathy attributed to chemotherapy treatment. Participants must exhibit clinical signs or symptoms consistent with tibial nerve involvement, such as distal lower limb pain, paresthesia, weakness, or altered sensation in the tibial nerve distribution. |
| Healthy Volunteers Group | – | Diagnostic Test: Shear Wave Elastography MeasurementThis group consists of adult participants with no known acute or chronic medical conditions, neurological disorders, or history of chemotherapy or neurotoxic drug exposure. Individuals must be in good general health, as determined by medical history, physical examination. This group serves as a control population to establish baseline measurements. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study included adults aged 18-75 years, divided into two groups: 25 patients with chemotherapy-induced peripheral neuropathy (CIPN) and DN4 scores ≥4, and 25 healthy controls without neuropathy symptoms. All participants underwent clinical screening and were anatomically suitable for tibial nerve ultrasound and shear wave elastography (SWE). Both tibial nerves were evaluated in each subject. Individuals with diabetes mellitus, alcohol use, genetic or toxic neuropathies, systemic diseases, lower limb trauma or lesions, or cognitive/psychiatric disorders affecting cooperation were excluded. The goal was to ensure a homogeneous population for accurate elastographic comparison.
Key inclusion criteria (4 listed)
- Age between 18 and 75 years
- DN4 score ≥4
- Anatomical suitability for tibial nerve ultrasound and SWE assessment
- Providing written informed consent
Key exclusion criteria (7 listed)
- Presence of diabetes mellitus
- Alcohol use
- Polyneuropathy due to genetic or toxic causes
- Fracture, skin lesion, or edema in the lower extremity
- Severe systemic diseases (e.g., liver, kidney, heart, or lung)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shear Wave Elastography MeasurementIt is a non-invasive imaging technique used to evaluate tissue stiffness. This method involves the use of ultrasound-based shear wave elastography to assess bilateral tibial nerve, by measuring the speed of shear wave propagation through the tissue. Stiffness values are expressed in kilopascals (kPa). | Diagnostic test | Chemotherapy-Induced Tibial Neuropathy Group, Healthy Volunteers Group |
Primary outcome
Shear Wave Elastography (SWE) Stiffness Value
Time frame: Single SWE measurement performed within the first week of study inclusion
Shear Wave Elastography (SWE) is an imaging technique used to quantify tissue stiffness by measuring the propagation speed (V, m/s) of shear waves and converting it into elasticity values (E, kilopascals, kPa). Higher values may indicate fibrosis or increased tension, while lower values may reflect fatty infiltration or atrophy. In peripheral nerves, SWE has been used to assess elasticity in neuropathic conditions. Research shows that affected nerves in neuropathy exhibit increased stiffness compared to healthy nerves. Both shear wave velocity (V) and elasticity modulus (E) can be measured, offering objective, quantitative data to detect and monitor structural nerve changes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy and Tibial Neuropathy, run by Ankara Etlik City Hospital at 1 site 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ufuk Turan (+905395594772 ext. TR, drufukturan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear Wave Elastography (SWE) Stiffness Value (time frame: Single SWE measurement performed within the first week of study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.