Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer
Condition: Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Observational

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).
    

Detailed description: 
      Purpose: The study has four aims;

        -  The primary aim of the study is to determine whether women who are receiving either
           weekly Taxol (80-100 mg/m2) or bi-weekly Taxol (i.e.,dose-dense; 175 mg/m2) show
           deficits in axon-reflex mediated vasodilation (AMV) over the course of six weeks of
           Taxol therapy similar to those that have been reported in patients with diabetic and
           genetically-inherited neuropathies.

        -  The second aim of the study is to determine whether women who are receiving either
           weekly or dose-dense Taxol develop changes in AMV before developing signs & symptoms of
           chemotherapy-induced peripheral neuropathy (CIPN) in a way that supports using changes
           in AMV as an early detection method for small-fiber CIPN.

        -  A third (exploratory) aim of the study is to determine whether any changes in AMV
           detected during the study are significantly correlated with self-reported CIPN in a way
           that would support using changes in AMV as a confirmatory marker for CIPN.

        -  A final (exploratory) aim of the study is to describe the size of axon reflexes and axon
           flares in women receiving weekly Taxol before they start their pre-Taxol anthracycline &
           cyclophosphamide (AC) therapy.
    

Intervention name(s): Axon Reflexes; Axon Flares; Self-Reported Signs & Symptoms of CIPN
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): *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).
Other intervention name(s): LDIflare, Heat-Evoked Axon Flare
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult women with breast cancer (WBC) and healthy female controls (HCs)
      
Keywords: Taxane; Neuropathy; Chemotherapy-Induced Peripheral Neuropathy (CIPN); Breast Cancer; Local skin heating; Axon reflex; Axon flare; Total Neuropathy Score (TNS); Laser Doppler Flowmetry (LDF); Laser Speckle Contrast Imaging (LSCI); Full-field laser perfusion imaging (FLPI); Paclitaxel; Taxol