Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

February 24, 2023 updated by: Nicole Williams, Ohio State University Comprehensive Cancer Center
Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.

Study Overview

Status

Completed

Conditions

Detailed Description

A study assessing the feasibility of evaluating neuropathy symptoms prospectively using testing of gate and balance parameters.

Study Type

Observational

Enrollment (Actual)

62

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
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Men and women diagnosed with breast cancer stages I-III

Description

Inclusion criteria

  • Patients (men and women) diagnosed with breast cancer stages I-III initiating first line adjuvant or neoadjuvant therapy with paclitaxel or docetaxel
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients with functional limitations due to musculoskeletal conditions can be included, because these conditions are known to remain stable over the relatively short duration of the study.
  • Concurrent standard and investigational agents are permissible with the standard chemotherapy drugs.

Exclusion Criteria

  • Prior known chemotherapy or targeted therapy (for breast cancer or other malignancies that is known to be associated with neuropathy in the last 12 months(platinum therapy, bortezomib, vinblastine, etc.)
  • Prior taxane exposure at any time
  • Preexisting known diagnosis of any type of neuropathy prior to start of paclitaxel or docetaxel chemotherapy
  • Pregnant or nursing women.
  • Unable to give informed consent.
  • Preexisting lower extremity amputation
  • Inability to walk or stand without assistance due to any condition
  • Neuropathic pain medications prior to start of study including gabapentin, pregabalin, amytriptyline, and duloxetine (but initiation of neuropathic pain medications during treatment are permissible)
  • Patients needing ambulatory assist devices
  • Back or lower extremity surgery in the last 6 months
  • Back or lower extremity surgery at any timepoint that interferes with gait and balance per patient or provider report

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
Breast cancer patients
This is a single arm study evaluating feasibility of evaluating gait and parameter changes in patients with early stage breast cancer undergoing adjuvant taxane chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify gait and balance parameters that are affected by during adjuvant/neoadjuvant taxane (paclitaxel or docetaxel) chemotherapy.
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the natural history of changes in these gait and balance parameters and their relationships with validated self-reported assessment tools of CIPN such as CIPN-20 and TNS
Time Frame: Up to 2 years
Up to 2 years
Identify gait and balance changes as a consequence of chemotherapy with paclitaxel or docetaxel in the laboratory measuring the motion of the entire body in three dimensions with great accuracy.
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

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

Sponsor

Ohio State University Comprehensive Cancer Center

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.

Helpful Links

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 (Actual)

December 4, 2013

Primary Completion (Actual)

May 14, 2018

Study Completion (Actual)

May 14, 2018

Study Registration Dates

First Submitted

April 23, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-13010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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