Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Maryam Lustberg, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02125019
First received: April 23, 2014
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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


Condition
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 ]

Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Maryam Lustberg, MD, MPH 614-293-8858 maryam.lustberg@osumc.edu

Locations
United States, Ohio
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Maryam Lustberg, MD, MPH    614-293-8858    Maryam.lustberg@osumc.edu   
Principal Investigator: Maryam Lustberg, MD, MPH         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Breast Cancer
Taxane
Gait
Men
Women

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

ClinicalTrials.gov processed this record on October 22, 2014