Peripheral NeuropathyNCT03139435
Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer
A study testing Biopsy, Questionnaire Administration and Ultrasound Tomography in people with Peripheral Neuropathy and Stage 0 Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This pilot clinical trial studies how well ultrasound works in detecting taxane-induced neuropathy in patients with breast cancer. Ultrasound may work better in diagnosing and detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a taxane. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Peripheral Neuropathy, Stage 0 Breast Cancer, Stage I Breast Cancer
- What is being tested?
- Biopsy, Questionnaire Administration and Ultrasound Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2017to 11 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Breast cancer (any stage)
- Previously or currently receiving taxane-based chemotherapy
- Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to taxane-based therapy
- Ability and willingness to understand and sign an informed consent
Who cannot join
- Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy
- Unable to provide history
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy
This pilot clinical trial studies how well ultrasound works in detecting taxane-induced neuropathy in patients with breast cancer. Ultrasound may work better in diagnosing and detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a taxane.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare tibial motor nerve ultrasound cross-sectional area (CSA) between taxane-induced peripheral neuropathy (TIPN) patients and historical data among healthy adults.
SECONDARY OBJECTIVES:
- To compare sural sensory nerve ultrasound CSA between TIPN patients and historical data among healthy adults.
II. To determine if the above changes in nerve CSA correlate with NCS changes in the same TIPN patients.
III. To determine if the above changes in nerve CSA correlate with changes on a self-reported neuropathy scale (Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 [QLQ-CIPN20]) in the same TIPN patients.
IV. To determine if the above changes in nerve CSA correlate with intraepidermal nerve fiber (IENF) density changes on skin biopsy in the same TIPN patients.
TERTIARY OBJECTIVES:
- To assess activated mast cells in skin biopsies in TIPN patients in relation to severity of symptoms and above findings.
II. To assess serum inflammatory markers in TIPN patients in relation to severity of symptoms and above findings.
OUTLINE:
Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.
After completion of study, patients are followed up for 30 days.
- Conditions
- Peripheral Neuropathy, Stage 0 Breast Cancer, Stage I Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- Being tested
- Biopsy, Questionnaire Administration, Ultrasound Tomography
- Medical subject headings
- Peripheral Nervous System Diseases, Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called Bx
Undergo skin biopsy
Questionnaire AdministrationOther
Ancillary studies
Ultrasound TomographyDiagnostic test
Undergo peripheral nerve ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (ultrasound) | Experimental | Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy. Receives: Procedure: Biopsy; Other: Questionnaire Administration; Diagnostic Test: Ultrasound Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibial Nerve Cross-sectional Area
Will be determined by ultrasound in the tibial nerve. Will be compared to the historical data from healthy patients using two-sample t-test (two-sample t-test selected as primary data from the historical control patients is available and will be used for analysis). Will also compare the nerve cross-sectional area in our study sample to that in the historical diabetic neuropathy patients and historical oxaliplatin neuropathy patients using one-sample t-test. The general linear model will be used to evaluate any factors (e.g., age) that may be associated with the nerve cross-sectional area. Due
Measured: Up to 30 days
Secondary outcomes (6)
Amplitude of Nerve Response - Ankle
Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (amplitude of nerve response - ankle).
Measured: Up to 30 days
Conduction Velocity of Nerve Response - Tibial
Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (conduction velocity of nerve response - tibial).
Measured: Up to 30 days
Distal Latency of Nerve Response - Ankle
Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area (tibial cross-sectional area) and nerve conduction studies (distal latency of nerve response - ankle).
Measured: Up to 30 days
Nerve Fiber Density in the Skin
Spearman's rank correlation coefficient will be used to examine the association between nerve cross-sectional area and distal intraepidermal nerve fiber density.
Measured: Up to 30 days
Self-reported Neuropathy Score
Will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20. Spearman's rank correlation coefficient will be used to examine the associations between the cross-sectional area and the self-reported neuropathy scale.
Measured: Up to 30 days
Sural Nerve Cross-sectional Area
Will be determined by ultrasound of the sural nerve. Spearman's rank correlation coefficient will be used to examine the associations between nerve cross-sectional area and nerve conduction studies. The general linear model will be also used to evaluate the association after adjusting for one or two risk factors (e.g., age). Nerve cross-sectional area will be treated as the dependent variable.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start11 May 2017
- Primary completion12 Dec 2018
- Study completion11 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roy Strowd, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139435
- Sponsor's protocol ID
- IRB00043631
- Other IDs
- NCI-2017-00680, CCCWFU 97217, P30CA012197
- Status last verified
- Apr 2024
- First submitted
- 1 May 2017
- Last updated
- 8 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03139435
- Acronym / sponsor ID
- IRB00043631
- Conditions
- Peripheral Neuropathy, Stage 0 Breast Cancer, Stage I Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 May 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Posted 8 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies how well ultrasound works in detecting taxane-induced neuropathy in patients with breast cancer. Ultrasound may work better in diagnosing and detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a taxane.
Detailed description
PRIMARY OBJECTIVES:
- To compare tibial motor nerve ultrasound cross-sectional area (CSA) between taxane-induced peripheral neuropathy (TIPN) patients and historical data among healthy adults.
SECONDARY OBJECTIVES:
- To compare sural sensory nerve ultrasound CSA between TIPN patients and historical data among healthy adults.
II. To determine if the above changes in nerve CSA correlate with NCS changes in the same TIPN patients.
III. To determine if the above changes in nerve CSA correlate with changes on a self-reported neuropathy scale (Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 [QLQ-CIPN20]) in the same TIPN patients.
IV. To determine if the above changes in nerve CSA correlate with intraepidermal nerve fiber (IENF) density changes on skin biopsy in the same TIPN patients.
TERTIARY OBJECTIVES:
- To assess activated mast cells in skin biopsies in TIPN patients in relation to severity of symptoms and above findings.
II. To assess serum inflammatory markers in TIPN patients in relation to severity of symptoms and above findings.
OUTLINE:
Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.
After completion of study, patients are followed up for 30 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (ultrasound) | Experimental | Procedure: Biopsy, Other: Questionnaire Administration, Diagnostic Test: Ultrasound TomographyPatients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Breast cancer (any stage)
- Previously or currently receiving taxane-based chemotherapy
- Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to taxane-based therapy
- Ability and willingness to understand and sign an informed consent
Key exclusion criteria (2 listed)
- Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy
- Unable to provide history
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 |
|---|---|---|
| BiopsyAlso: BxUndergo skin biopsy | Procedure or surgery | Diagnostic (ultrasound) |
| Questionnaire AdministrationAncillary studies | Other | Diagnostic (ultrasound) |
| Ultrasound TomographyUndergo peripheral nerve ultrasound | Diagnostic test | Diagnostic (ultrasound) |
Primary outcome
Tibial Nerve Cross-sectional Area
Time frame: Up to 30 days
Will be determined by ultrasound in the tibial nerve. Will be compared to the historical data from healthy patients using two-sample t-test (two-sample t-test selected as primary data from the historical control patients is available and will be used for analysis). Will also compare the nerve cross-sectional area in our study sample to that in the historical diabetic neuropathy patients and historical oxaliplatin neuropathy patients using one-sample t-test. The general linear model will be used to evaluate any factors (e.g., age) that may be associated with the nerve cross-sectional area. Due
6 secondary outcomes
Amplitude of Nerve Response - Ankle
Time frame: Up to 30 days
Conduction Velocity of Nerve Response - Tibial
Time frame: Up to 30 days
Distal Latency of Nerve Response - Ankle
Time frame: Up to 30 days
Nerve Fiber Density in the Skin
Time frame: Up to 30 days
Self-reported Neuropathy Score
Time frame: Up to 30 days
Sural Nerve Cross-sectional Area
Time frame: Up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Roy Strowd principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy, Questionnaire Administration and Ultrasound Tomography in people with Peripheral Neuropathy and Stage 0 Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
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 2 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 8 Apr 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tibial Nerve Cross-sectional Area (time frame: Up to 30 days). 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 8 Apr 2024.