Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer
Verified July 2015 by Ohio State University Comprehensive Cancer Center
Information provided by (Responsible Party):
Maryam Lustberg, Ohio State University Comprehensive Cancer Center
First received: April 23, 2014
Last updated: July 27, 2015
Last verified: July 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 ]
| Estimated Enrollment:
| 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
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
|Ohio State University Wexner Medical Center
|Columbus, Ohio, United States, 43210 |
|Contact: Maryam Lustberg, MD, MPH 614-293-8858 Maryam.firstname.lastname@example.org |
|Principal Investigator: Maryam Lustberg, MD, MPH |
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
||July 27, 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 July 29, 2015
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