Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT02549534
Eligibility Criteria:
Inclusion Criteria for Women with Breast Cancer:
* Age 18-85
* Able to read, write, and understand English
* Diagnosed with histologically-confirmed, first-time, non-metastatic breast cancer (stage I-IIIB)
* No prior exposure to neurotoxic chemotherapy or radiation at the time of enrollment,
* Will be receiving weekly paclitaxel (Taxol® or generic paclitaxel, 80- 100mg/m2) or bi-weekly Taxol (i.e., dose-dense; 175 mg/m2) as a part of their cancer treatment regimen OR
* Will be receiving an anthracycline and cyclophosphamide (AC) followed by weekly paclitaxel (Taxol® or generic paclitaxel, 80-100mg/m2) or bi-weekly Taxol (i.e., dose-dense; 175 mg/m2) as a part of their cancer treatment regimen;
Inclusion Criteria for Healthy Controls:
* Aged 18-85
* Can read, write, and understand English
Exclusion Criteria:
* A history of cardiovascular disease, hypertension, or peripheral arterial/vascular disease;
* Current use of (1) medications/supplements to control blood pressure (e.g. beta-blockers, nitrates, calcium channel blockers, Phosphodiesterase-5 (PGE5) inhibitors) or (2) the use of statins for cholesterol;
* Suspected or diagnosed diabetes (with the exception of gestational diabetes);
* Pre-existing neuropathy, neuropathic pain, or nerve injury;
* Pain or significant arthritis in the toes of either foot;
* Current skin disease or fungal infection of the feet;
* Significant damage or deformity to the feet that would alter blood flow or make it impossible to measure/interpret findings;
* Diagnosed or suspected vasospastic disease such as Raynaud's syndrome;
* Current use of tobacco/tobacco-containing products;
* Diagnosis of restless leg syndrome or other movement disorders that would prevent accurate data from being able to be collected.
In-Study Restrictions:
* No caffeine- or alcohol-containing products for 12 hours prior to their study visit;
* No food for at least one hour prior to blood flow monitoring;
* No non-steroidal anti-inflammatory drugs (NSAIDS) for 24 hours prior to study visits unless directed by a physician to do so.
(Note: These restrictions are designed to improve the rigor and quality of the data, but non-compliance will not be grounds for study exclusion; adherence to these restrictions will be monitored during self-report).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02549534
Study Brief:
Protocol Section:
NCT02549534