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The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients (IPMR Balance)

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ClinicalTrials.gov Identifier: NCT02391818
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Illinois CancerCare, P.C.
University of Illinois College of Medicine at Peoria
St. Francis Hospitals & Health Centers
Information provided by (Responsible Party):
Catherine Horst, 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.

Condition or disease
Distorted; Balance Quality of Life Neuropathy Cancer

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.

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients
Study Start Date : February 2015
Actual Primary Completion Date : June 16, 2017
Actual Study Completion Date : June 16, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Breast Cancer Patients receiving ACT
Adraimycin/Cytoxan/Taxol
Breast Cancer patients receiving RT only
radiation therapy



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from cancer treatment clinic and radiation oncology clinics
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391818


Locations
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United States, Illinois
Illinois CancerCare
Pekin, Illinois, United States, 61554
OSF Radiation Oncology
Pekin, Illinois, United States, 61554
Illinois CancerCare
Peoria, Illinois, United States, 61615
OSF Radiation Oncology
Peoria, Illinois, United States, 61615
Sponsors and Collaborators
OSF Healthcare System
Illinois CancerCare, P.C.
University of Illinois College of Medicine at Peoria
St. Francis Hospitals & Health Centers
Investigators
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Study Director: Carl Asche, PhD University of Illinois College of Medicine at Peoria
Study Director: Jinma Ren, PhD University of Illinois College of Medicine at Peoria
Principal Investigator: Catherine Horst, DPT IPMR
Study Director: Nguyet Le-Lindqwister, MD Illinois CancerCare
Study Director: Anthony Zalduendo, MD OSF Radiation Oncology

Publications:

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Responsible Party: Catherine Horst, Principle Investigator, Physical Therapist, OSF Healthcare System
ClinicalTrials.gov Identifier: NCT02391818     History of Changes
Other Study ID Numbers: 599231-1
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Catherine Horst, OSF Healthcare System:
balance
quality of life
chemotherapy
neuropathy
cancer
Additional relevant MeSH terms:
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Taxane
Antineoplastic Agents