Breast Cancer Clinical Trial
Official title:
Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer
NCT number | NCT02125019 |
Other study ID # | OSU-13010 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 4, 2013 |
Est. completion date | May 14, 2018 |
Verified date | February 2023 |
Source | Ohio State University Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.
Status | Completed |
Enrollment | 62 |
Est. completion date | May 14, 2018 |
Est. primary completion date | May 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Wexner Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identify gait and balance parameters that are affected by during adjuvant/neoadjuvant taxane (paclitaxel or docetaxel) chemotherapy. | Up to 2 years | ||
Secondary | 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 | Up to 2 years | ||
Secondary | 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. | Up to 2 years |
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