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
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer
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 ]
| Study Start Date:
| 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.
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:
|Accepts Healthy Volunteers:
Men and women diagnosed with breast cancer stages I-III
- 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.
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02125019
|Ohio State University Wexner Medical Center
|Columbus, Ohio, United States, 43210 |
Ohio State University Comprehensive Cancer Center
||Maryam Lustberg, MD, MPH
||Ohio State University Comprehensive Cancer Center
No publications provided
||Maryam Lustberg, Principal Investigator, Ohio State University Comprehensive Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 23, 2014
||January 13, 2015
||United States: Institutional Review Board
Keywords provided by Ohio State University Comprehensive Cancer Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015
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