Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02125019
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.

Detailed Description

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

Study Timeline

• Study Start: 2013-12-04
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-29
• Primary Completion: 2018-05-14
• Study Completion: 2018-05-14
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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.	Up to 2 years

Trial Locations

Locations (1)

Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States