Clinical trial NCT02391818: The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients
Official title: The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distorted; Balance
Quality of Life
Neuropathy
Cancer
Keywords: balance
quality of life
chemotherapy
neuropathy
cancer
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
Collaborators: name: Illinois CancerCare, P.C.
name: University of Illinois College of Medicine at Peoria
name: St. Francis Hospitals & Health Centers
First posted: 2015-03-18
Enrollment: 19
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from cancer treatment clinic and radiation oncology clinics

Brief summary: The purpose of this study is to quantify the balance impairments during and after taxane chemotherapy. Disability due to balance impairments caused by chemotherapy induced peripheral neuropathy (CIPN) can cause falls, injury, and a decline in independence. This results in poor treatment outcomes such as greater morbidity and mortality, inability to complete treatment protocols, self-limitation of activity, and diminished quality of life.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Modified Clinical Test of Sensory Integration of Balance at 9 months.
timeFrame: An average of 5 months for the controls, and 9 months for the cases.
Secondary outcomes:
measure: Change from baseline Five Times Sit to STand
timeFrame: An average of 5 months for the controls, and 9 months for the cases.
measure: Change from baseline Visual Contrast Sensitivity
timeFrame: An average of 5 months for the controls, and 9 months for the cases.
measure: Change from baseline Touch Detection Threshold
timeFrame: An average of 5 months for the controls, and 9 months for the cases.
measure: Change from baseline Patient Neurotoxicity Questionnaire
timeFrame: An average of 5 months for the controls, and 9 months for the cases.
measure: Change from baseline Patient Neuropathy Function Questionnaire
timeFrame: An average of 5 months for the controls, and 9 months for the cases.
measure: Change from baseline Edmonton Symptom Assessment Scale
timeFrame: An average of 5 months for the controls, and 9 months for the cases.
Other outcomes:
Locations:
city: Pekin
country: United States
facility: Illinois CancerCare
state: Illinois
city: Pekin
country: United States
facility: OSF Radiation Oncology
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare
state: Illinois
city: Peoria
country: United States
facility: OSF Radiation Oncology
state: Illinois
Study officials:
affiliation: University of Illinois College of Medicine at Peoria
name: Carl Asche, PhD
role: STUDY_DIRECTOR
affiliation: University of Illinois College of Medicine at Peoria
name: Jinma Ren, PhD
role: STUDY_DIRECTOR
affiliation: IPMR
name: Catherine Horst, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Illinois CancerCare
name: Nguyet Le-Lindqwister, MD
role: STUDY_DIRECTOR
affiliation: OSF Radiation Oncology
name: Anthony Zalduendo, MD
role: STUDY_DIRECTOR
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