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

NCT01163682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2023-09-21

Study results available
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Summary

This study seeks to determine if 12 weeks of weekly electro-acupuncture will prevent or decrease neuropathic pain in breast cancer patients receiving 12 weekly treatments of taxane treatment.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Dawn L Hershman, MD, MS · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-12-31
Completion
2017-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01163682 on ClinicalTrials.gov