Columbus, Ohio 43210


Purpose:

Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.


Study summary:

A study assessing the feasibility of evaluating neuropathy symptoms prospectively using testing of gate and balance parameters.


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


NCT ID:

NCT02125019


Primary Contact:

Principal Investigator
Maryam Lustberg, MD, MPH
Ohio State University Comprehensive Cancer Center

Ohio State University Comprehensive Cancer Center
Email: OSUCCCClinicaltrials@osumc.edu


Backup Contact:

Email: Lynette.Mesi@osumc.edu
Lynette Mesi
Phone: 614-293-6669


Location Contact:

Columbus, Ohio 43210
United States

Maryam Lustberg, MD, MPH
Phone: 614-293-8858
Email: Maryam.lustberg@osumc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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