At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer
In Brief
An observational study evaluating Axon Reflexes, Axon Flares, and 1 other intervention for Peripheral Neuropathy. Completed, enrolled 29 participants across 2 sites.
Detailed Summary
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).
Study Details
Timeline
Interventions
\*Axon reflexes will be evoked in the palmar surface of the right great toe using local skin heating with a 0.33 cm2 heat probe using the following protocol: * Baseline: Heating the skin of the toe for a minimum of 5 minutes at 33\*C. * Heat Ramp: Increasing the heat in the heat probe to 42\*C at approx. 0.1\*C/10 sec. * Skin Heating: Heating the skin of the toe for 30 minutes 42\*C. * Heat Ramp: Increasing the heat in the heat probe to 44\*C at 0.1\*C/10 sec.. * Skin Heating: Heating the skin for an additional 5 minutes at 44\*C. The size of the axon reflex during this skin heating protocol will be imaged using Laser Doppler Flowmetry (LDF). In the case that participants develop CIPN on their left side only, the left toe will be substituted.
Axon flares will be generated on the palmar surface of the right great toe using the same local skin heating protocol described above, and imaged using a laser speckle contrast imager (LSCI) (also known as full-field laser perfusion imager, or FLPI).
Self-reported signs \& symptoms of CIPN such as the presence and location of (1) tingling, (2) numbness, and (3) neuropathic pain, along with information about (4) deficits in vibration thresholds, and (5) loss of deep tendon reflexes will be assessed at each study visit using the 5-item, modified Total Neuropathy Score (mTNS).