The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients

The purpose of this study is to describe the balance deficits prior to the initiation of
taxane therapy and through the duration of treatment and compare balance to a cohort of women
without taxane therapy. To our knowledge, a study like this has not been done yet it is a
necessary next step in order to evaluate whether balance deficits resolve independent of
treatment or if the balance deficits require targeted therapy. Other studies evaluating
balance in taxane patients, have used cross-sectional study designs that are limited to
observation at one point in time. Further, other evaluations have been limited in the
measurement of balance using only self-report questionnaires, with no performance
measurements of functional balance. Previous studies of other conditions have shown poor
concordance between self-report questionnaires and performance measures. Therefore, our
proposed longitudinal study improves the current knowledge about balance deficits during
taxane therapy by quantifying the impact of taxane chemotherapy on balance during and after
treatment using standardized and validated self-report and performance functional balance
assessment tools. The results of this study will improve the treatment of balance deficits in
women with taxane therapy by identifying the type, onset, duration, and severity of the
deficits within each balance system. From these findings, targeted interventions, if
required, could be developed. In addition, establishing feasibility and utility for
quantifying balance impairments is necessary for the development of larger studies assessing
the effects of rehabilitation interventions on functional disability due to CIPN. Such a
study would be worthy of influencing changes in clinical practice to minimize disability from
balance dysfunction before, during, and after chemotherapy, and thus maximizing function and
quality of life during and after cancer treatment.

Inclusion Criteria:

1. Women with breast cancer (stage 0-III)

2. Scheduled to receive any of the following individual treatment protocols:

1. ACT

2. Radiation only

Exclusion Criteria:

1. Required assistive device for ambulation in the 6 months prior to starting treatment

2. Previous taxane or platinum chemotherapy (paclitaxel/Taxol®, docetaxel/Taxotere®,
cabazitaxel/Jevtana®, cisplatin, carboplatin, and oxaliplatin)

3. Inability to stand or walk without assistance

4. BMI >40 (see chart below)

5. Pre-existing vestibular, visual, somatosensory, orthopedic, and neurologic disease
before entering the study including but not limited to being legally blind (ICD9
368.3, 369.0-369.2 lower extremity amputation (ICD9 895.0-897.7), and Diabetes (ICD9
249.0-250.93, 257.2)

6. Evidence of central nervous system metastasis

7. Cognitive difficulties or medical conditions that, in the opinion of the study
investigators, will affect testing protocols

8. Enrollment in other trial aimed at treating CIPN.