The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients

Completed

• Conditions: Distorted; Balance; Quality of Life; Cancer; Neuropathy

• Registration Number: NCT02391818
• Lead Sponsor: OSF Healthcare System

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-18
• Primary Completion: 2017-06-16
• Study Completion: 2017-06-16
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline Modified Clinical Test of Sensory Integration of Balance at 9 months.	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 Outcome Measures

Name	Time	Method
Change from baseline Five Times Sit to STand	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
Change from baseline Touch Detection Threshold	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
Change from baseline Patient Neurotoxicity Questionnaire	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
Change from baseline Visual Contrast Sensitivity	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
Change from baseline Patient Neuropathy Function Questionnaire	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
Change from baseline Edmonton Symptom Assessment Scale	An average of 5 months for the controls, and 9 months for the cases.	Quality of life scale validated for the breast cancer population

Trial Locations

Locations (2)

Illinois CancerCare; 🇺🇸 Peoria, Illinois, United States

OSF Radiation Oncology; 🇺🇸 Peoria, Illinois, United States