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

August 26, 2019 updated by: Catherine Horst, OSF Healthcare System
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare
      • Pekin, Illinois, United States, 61554
        • OSF Radiation Oncology
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare
      • Peoria, Illinois, United States, 61615
        • OSF Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients from cancer treatment clinic and radiation oncology clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Breast Cancer Patients receiving ACT
Adraimycin/Cytoxan/Taxol
Breast Cancer patients receiving RT only
radiation therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
An average of 5 months for the controls, and 9 months for the cases.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
An average of 5 months for the controls, and 9 months for the cases.
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
An average of 5 months for the controls, and 9 months for the cases.
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
An average of 5 months for the controls, and 9 months for the cases.
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
An average of 5 months for the controls, and 9 months for the cases.
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
An average of 5 months for the controls, and 9 months for the cases.
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
An average of 5 months for the controls, and 9 months for the cases.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OSF Healthcare System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Illinois College of Medicine at Peoria
St. Francis Hospitals & Health Centers
Illinois CancerCare, P.C.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 16, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 599231-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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