Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Maryam Lustberg, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
First received: April 23, 2014
Last updated: January 13, 2015
Last verified: January 2015

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

Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

Resource links provided by NLM:

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Identify gait and balance parameters that are affected by during adjuvant/neoadjuvant taxane (paclitaxel or docetaxel) chemotherapy. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

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 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: September 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.

Detailed Description:

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Men and women diagnosed with breast cancer stages I-III


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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02125019

United States, Ohio
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Principal Investigator: Maryam Lustberg, MD, MPH Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Maryam Lustberg, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02125019     History of Changes
Other Study ID Numbers: OSU-13010
Study First Received: April 23, 2014
Last Updated: January 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015