Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer
Completed
Conditions studied: Peripheral Neuropathy
In brief
Purpose: The purpose of the study is to test a new way of measuring nerve damage in women with breast cancer receiving chemotherapy drug paclitaxel (Taxol).
Key facts
- Study ID
- NCT02549534
- Run by
- Indiana University
- People needed
- 29
- Starts
- 2015-09-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2017-10-27
Who can join
Age: 18 and older, up to 85. Sex: female. Healthy volunteers: accepted.
You may not qualify if…
- 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).
Where it is running
- Indiana University Melvin and Bren Simon Cancer Center (IUSCC) — Indianapolis, Indiana, United States
- Syndney & Lois Eskenazi Health Center — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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