Clinical trial · Interventional
Ultrasound in Detecting Taxane-Induced Neuropathy in Patients With Breast Cancer
A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy
NCT03139435CI-TRIAL-00075817completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy | — | UNRESOLVED | — |
| Stage 0 Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Ultrasound Tomography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (ultrasound)
- description
- Patients undergo peripheral nerve ultrasound. Patients also undergo skin biopsy.
- interventionNames
- Procedure: Biopsy
- Other: Questionnaire Administration
- Diagnostic Test: Ultrasound Tomography
Primary outcomes (1)
- measure
- Tibial Nerve Cross-sectional Area
- timeFrame
- Up to 30 days
- description
- 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
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy * Unable to provide history
References
Publications (0)
Data not yet available
No reference posted for this study.