Clinical trial · Observational
Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer
NCT01153282CI-TRIAL-00043935completedClinicalTrials.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)
Determine the characteristics of symptoms and functional impairment associated with chemotherapy induced peripheral neuropathy.
Conditions
Conditions (1)
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 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of interviews
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Women 21-70 years old (Women over 70 are offered chemotherapy less frequently because of their risk benefit ratio. Including them would be a selection bias because of their differential underexposure). * Initiated taxane-based chemotherapy in the neoadjuvant, adjuvant, or previously untreated metastatic setting. * The range of exposure to taxane-based chemotherapy will include women on active treatment having received two cycles, to women who are within three months of their last infusion. * Documented symptoms of CIPN per CTCAE grading criteria (half of sample) or NO symptoms (half of sample) Grade 0 = no CIPN symptoms Grade 1 = mild symptoms Grade 2 = moderate symptoms - prescribed Gabapentin (Neurontin) Grade 3\&4= severe symptoms - treated with Gabapentin (Neurontin), treatment plan altered Exclusion Criteria: * Physical disabilities - defined by use of assistive devices to complete functional tasks (wheelchair, crutches, prosthetic limbs) prior to starting chemotherapy. * Current exposure to neurotoxic agents (Navelbine, platinums or other taxanes) * Pregnancy during chemotherapy treatment * Diabetes - diagnosed 3 or more years , or insulin dependent, or with clinically established neuropathy * Previous exposure to chemotherapy or radiotherapy * HIV positive (high risk for neuropathy) * Other neurological diseases, such as Multiple Sclerosis * Other pre-existing neuropathy
References
Publications (0)
Data not yet available
No reference posted for this study.