Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/5/2018 |
Start Date: | September 25, 2013 |
End Date: | December 31, 2019 |
Contact: | Ohio State University Comprehensive Cancer Center |
Email: | OSUCCCClinicaltrials@osumc.edu |
Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.
A study assessing the feasibility of evaluating neuropathy symptoms prospectively using
testing of gate and balance parameters.
testing of gate and balance parameters.
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
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Maryam Lustberg, MD, MPH
Phone: 614-293-8858
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
Click here to add this to my saved trials