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

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).

Conditions

• Peripheral Neuropathy

Interventions

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).

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Midwest Nursing Research Society (MNRS)

  collaborator UNKNOWN

• Council for the Advancement of Nursing Science (CANS)

  collaborator UNKNOWN

• Indiana Center for Vascular Biology & Medicine (ICVBM)

  collaborator UNKNOWN

• Indiana University School of Medicine

  collaborator OTHER

• Indiana University

  lead OTHER

Principal Investigators

• Victoria L. Champion, PhD,RN,FAAN · Indiana University School of Medicine

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2016-07-31

Completion

2016-07-31

Countries

• United States

Study Locations