NCT02549534

Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Peripheral Neuropathy

Interventions

Type	Name	Description
PROCEDURE	Axon Reflexes	\*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.
PROCEDURE	Axon Flares	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).
PROCEDURE	Self-Reported Signs & Symptoms of CIPN	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).

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-09-15
• Last updated: 2017-10-27

Locations

2 sites across 1 country: United States