Clinical trial · Observational
Objective Evaluation of Paclitaxel/Docetaxel-induced Neuropathy in Breast Cancer Patients
NCT03872141CI-TRIAL-00051588completedClinicalTrials.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)
The purpose of this prospective, non-interventional study is to perform neurological and cognitive assessment of breast cancer patients who receive standard of care single agent weekly paclitaxel docetaxel chemotherapy to determine the onset and severity of chemotherapy induced neuropathy (CIPN) and cognitive impairment (CICI).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy Induced Peripheral Neuropathy | — | UNRESOLVED | — |
| Paclitaxel Induced Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancer | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- patients with stage I-III breast cancer
- description
- Patients with Stage I-III breast cancer who will receive paclitaxel or docetaxel treatments as part of their standard of care adjuvant or neoadjuvant therapy are eligible for this study.
- interventionNames
- Diagnostic Test: Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancer
Primary outcomes (6)
- measure
- Verbal Memory Test
- timeFrame
- 20 minutes
- description
- The phrase "Shopping List Learning" is displayed on screen. The pre-task on-screen instructions tell the test supervisor to start this task with the screen facing the supervisor so that the subject cannot see the screen. There are 3 initial rounds of this test. In the first round, the subject is told by the test supervisor: "In this task, I am going to read you a shopping list. I would like you to remember as many items from this list as possible.Total number of correct responses made in remembering the 16 word list on three consecutive learning trials. (Higher score = better performance)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Women ages 18 to 70 with histologically confirmed clinically stage I-III breast cancer who will receive weekly paclitaxel (80 mg/m2) or docetaxel (60-100mg/m2) chemotherapy as part of their routine care. Exclusion Criteria: * diabetes mellitus * prior history of neuropathy or symptoms of numbness or peripheral pain, or prior neurotoxic chemotherapy. * current symptoms of numbness and neuropathic pain * treatment for bipolar disease * treatment or concomitant use of common medications used to treat neuropathic pain, such as amitriptyline, gabapentin, pregabalin, duloxetine, for any indication * limited English that would preclude understanding and completion of the study questionnaires * pregnancy * life expectancy \<12 weeks * participation in other research studies either concurrent with or within 30 days prior to participation in this study may be an exclusion criteria
References
Publications (0)
Data not yet available
No reference posted for this study.