Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer (NCT02125019) | Clinical Trial Compass
CompletedNot Applicable
Longitudinal Evaluation of Taxane Induced Neuropathy in Early Stage Breast Cancer
United States62 participantsStarted 2013-12-04
Plain-language summary
Longitudinal Evaluation of Taxane induced neuropathy in early stage breast cancer.
Who can participate
Age range18 Years
SexALL
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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 pat…
What they're measuring
1
Identify gait and balance parameters that are affected by during adjuvant/neoadjuvant taxane (paclitaxel or docetaxel) chemotherapy.
Timeframe: Up to 2 years
Trial details
NCT IDNCT02125019
SponsorOhio State University Comprehensive Cancer Center