Breast Cancer
Conditions
Keywords
Breast Cancer, Taxane, Gait, Men, Women
Brief summary
Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.
Detailed description
A study assessing the feasibility of evaluating neuropathy symptoms prospectively using testing of gate and balance parameters.
Interventions
None listed
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identify gait and balance parameters that are affected by during adjuvant/neoadjuvant taxane (paclitaxel or docetaxel) chemotherapy. | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the natural history of changes in these gait and balance parameters and their relationships with validated self-reported assessment tools of CIPN such as CIPN-20 and TNS | Up to 2 years |
| Identify gait and balance changes as a consequence of chemotherapy with paclitaxel or docetaxel in the laboratory measuring the motion of the entire body in three dimensions with great accuracy. | Up to 2 years |
Countries
United States
Outcome results
None listed