Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02125019

Collaborator

(none)

Enrollment

Location

87.2

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

62 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

Actual Study Start Date :

Sep 25, 2013

Actual Primary Completion Date :

May 14, 2018

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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