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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

April 23, 2014
April 24, 2014
September 2013
December 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT02125019 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer
Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer

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

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Men and women diagnosed with breast cancer stages I-III

Breast Cancer
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
United States
 
NCT02125019
OSU-13010
Yes
Maryam Lustberg, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: Maryam Lustberg, MD, MPH Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP