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

CompletedOBSERVATIONAL
Enrollment

29

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

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).

Trial Locations (2)

46202

Indiana University Melvin and Bren Simon Cancer Center (IUSCC), Indianapolis

Syndney & Lois Eskenazi Health Center, Indianapolis

All Listed Sponsors
collaborator

National Institute of Nursing Research (NINR)

NIH

collaborator

Midwest Nursing Research Society (MNRS)

UNKNOWN

collaborator

Council for the Advancement of Nursing Science (CANS)

UNKNOWN

collaborator

Indiana Center for Vascular Biology & Medicine (ICVBM)

UNKNOWN

collaborator

Indiana University School of Medicine

OTHER

lead

Indiana University

OTHER

NCT02549534 - Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer | Biotech Hunter | Biotech Hunter