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Completed

NCT Number: NCT02391818

The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Illinois CancerCare, Pekin, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with breast cancer (stage 0-III)
  • Scheduled to receive any of the following individual treatment protocols:
  • ACT
  • Radiation only

Exclusion criteria

  • Required assistive device for ambulation in the 6 months prior to starting treatment
  • Previous taxane or platinum chemotherapy (paclitaxel/Taxol®, docetaxel/Taxotere®, cabazitaxel/Jevtana®, cisplatin, carboplatin, and oxaliplatin)
  • Inability to stand or walk without assistance
  • BMI >40 (see chart below)
  • 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)
  • Evidence of central nervous system metastasis
  • Cognitive difficulties or medical conditions that, in the opinion of the study investigators, will affect testing protocols
  • Enrollment in other trial aimed at treating CIPN.

Treatment and study plan

Primary outcomes

  1. Change from baseline Modified Clinical Test of Sensory Integration of Balance at 9 months.

    Time frame: An average of 5 months for the controls, and 9 months for the cases.

    assessment of static balance under conditions eyes open on firm surface, eyes closed on firm surface, eyes open on foam surface, and eyes closed on foam surface

Secondary outcomes

  1. Change from baseline Five Times Sit to STand

    Time frame: An average of 5 months for the controls, and 9 months for the cases.

    Time in seconds it takes to stand up and sit down from a standard height chair

  2. Change from baseline Visual Contrast Sensitivity

    Time frame: An average of 5 months for the controls, and 9 months for the cases.

    Using the Mars Letter Chart, a contrast sensitivity score is calculated

  3. Change from baseline Touch Detection Threshold

    Time frame: An average of 5 months for the controls, and 9 months for the cases.

    The lightest Von Frey Filament able to be detected using the up/down method is recorded on 3 places of each foot

  4. Change from baseline Patient Neurotoxicity Questionnaire

    Time frame: An average of 5 months for the controls, and 9 months for the cases.

    Likert scale describing the level of intensity of lower extremity neuropathy symptoms and their interference with functional activities

  5. Change from baseline Patient Neuropathy Function Questionnaire

    Time frame: An average of 5 months for the controls, and 9 months for the cases.

    number of falls are recorded, as well as Likert scales for various functional activities

  6. Change from baseline Edmonton Symptom Assessment Scale

    Time frame: An average of 5 months for the controls, and 9 months for the cases.

    Quality of life scale validated for the breast cancer population

Sponsors and collaborators

Lead sponsor

OSF Healthcare System

Other

Collaborators

  • Illinois CancerCare, P.C.
  • St. Francis Hospitals & Health Centers
  • University of Illinois College of Medicine at Peoria

Registry information

Acronym: IPMR Balance

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 18, 2015
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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