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Completed

NCT Number: NCT02125019

Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identify gait and balance parameters that are affected by during adjuvant/neoadjuvant taxane (paclitaxel or docetaxel) chemotherapy.

    Time frame: Up to 2 years

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2014
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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