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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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