Breast Cancer Clinical Trial
Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer
Summary
Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.
Full Description
A study assessing the feasibility of evaluating neuropathy symptoms prospectively using testing of gate and balance parameters.
Eligibility Criteria
Inclusion criteria
Patients (men and women) diagnosed with breast cancer stages I-III initiating first line adjuvant or neoadjuvant therapy with paclitaxel or docetaxel
Ability to understand and the willingness to sign a written informed consent document.
Patients with functional limitations due to musculoskeletal conditions can be included, because these conditions are known to remain stable over the relatively short duration of the study.
Concurrent standard and investigational agents are permissible with the standard chemotherapy drugs.
Exclusion Criteria
Prior known chemotherapy or targeted therapy (for breast cancer or other malignancies that is known to be associated with neuropathy in the last 12 months(platinum therapy, bortezomib, vinblastine, etc.)
Prior taxane exposure at any time
Preexisting known diagnosis of any type of neuropathy prior to start of paclitaxel or docetaxel chemotherapy
Pregnant or nursing women.
Unable to give informed consent.
Preexisting lower extremity amputation
Inability to walk or stand without assistance due to any condition
Neuropathic pain medications prior to start of study including gabapentin, pregabalin, amytriptyline, and duloxetine (but initiation of neuropathic pain medications during treatment are permissible)
Patients needing ambulatory assist devices
Back or lower extremity surgery in the last 6 months
Back or lower extremity surgery at any timepoint that interferes with gait and balance per patient or provider report
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There is 1 Location for this study
Columbus Ohio, 43210, United States
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