Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

The Ohio State University

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02125019

OSU-13010

Details and patient eligibility

About

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

Full description

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

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

62 participants in 1 patient group

Breast cancer patients

Description:

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.