Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

Study Overview
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Brief Summary
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Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.

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

Official Title
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Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer patients<br>This is a single arm study evaluating feasibility of evaluating gait and parameter changes in patients with early stage breast cancer undergoing adjuvant taxane chemotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify gait and balance parameters that are affected by during adjuvant/neoadjuvant taxane (paclitaxel or docetaxel) chemotherapy. |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Men, Breast Cancer, Taxane, Gait, Women