Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

Taxanes, a type of chemotherapeutic agent prescribed to breast cancer patients, have a known
physical side effect of chemotherapy induced peripheral neuropathy (CIPN). The purpose of
this qualitative study is to understand the experience and physical functional side effects
of taxanes. This is the first of a two phase study. The overall goal is to identify existing
objective physical performance measures to assess functional side effects of taxanes.

Inclusion Criteria:

- Women 21-70 years old (Women over 70 are offered chemotherapy less frequently because
of their risk benefit ratio. Including them would be a selection bias because of their
differential underexposure).

- Initiated taxane-based chemotherapy in the neoadjuvant, adjuvant, or previously
untreated metastatic setting.

- The range of exposure to taxane-based chemotherapy will include women on active
treatment having received two cycles, to women who are within three months of their
last infusion.

- Documented symptoms of CIPN per CTCAE grading criteria (half of sample) or NO symptoms
(half of sample) Grade 0 = no CIPN symptoms Grade 1 = mild symptoms Grade 2 = moderate
symptoms - prescribed Gabapentin (Neurontin) Grade 3&4= severe symptoms - treated with
Gabapentin (Neurontin), treatment plan altered

Exclusion Criteria:

- Physical disabilities - defined by use of assistive devices to complete functional
tasks (wheelchair, crutches, prosthetic limbs) prior to starting chemotherapy.

- Current exposure to neurotoxic agents (Navelbine, platinums or other taxanes)

- Pregnancy during chemotherapy treatment

- Diabetes - diagnosed 3 or more years , or insulin dependent, or with clinically
established neuropathy

- Previous exposure to chemotherapy or radiotherapy

- HIV positive (high risk for neuropathy)

- Other neurological diseases, such as Multiple Sclerosis

- Other pre-existing neuropathy