Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy

NACompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

December 31, 2015

Study Completion Date

May 31, 2017

Conditions
Breast CancerNeuropathy
Interventions
DEVICE

Electro-acupuncture

Subjects will be placed in prone position and acupuncture sites will be cleaned with alcohol preparation. Stainless steel disposable acupuncture needle (diameter 0.25mm) will be inserted into the skin to appropriate depth needed to elicit de qi(approximately 3-4mm). Selected acupuncture points will be attached to2 leads connected to an electro-stimulator that generates 2 Hz of mixed pulsatile intervals for a total of 30 minutes. The acupuncturist will return two times during the treatment at 10 and 20 minutes with needles in situ to check on the patients and needles. Needles not attached to the electro-stimulator will be manipulated manually to elicit de qi one time during the treatment.

DEVICE

Sham acupuncture

Will be utilizing a sham control that consists of collapsible acupuncture needle so that there is no penetration of skin. The sham needles will be place on 4 non specific body points. The electro-stimulator will be attached to the needles for 30 minutes but will not be turned on. The acupuncturist will return two times during the treatment at 10 and 20 minutes to check on the patient. The acupuncturist will touch the collapsible acupuncture needs to simulate the manipulation of the needles.

Trial Locations (1)

10032

Columbia University Medical Center, New York

Sponsors
All Listed Sponsors
collaborator

Breast Cancer Research Foundation

OTHER

lead

Columbia University

OTHER