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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02125019
Other study ID # OSU-13010
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 4, 2013
Est. completion date May 14, 2018

Study information

Verified date February 2023
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date May 14, 2018
Est. primary completion date May 14, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Ohio State University Wexner Medical Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identify gait and balance parameters that are affected by during adjuvant/neoadjuvant taxane (paclitaxel or docetaxel) chemotherapy. Up to 2 years
Secondary 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
Secondary 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
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