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

NCT01163682 | Completed Results FDA Device

• 1 other identifier: AAAE7054
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Neuropathy

Keywords

taxane induced neuropathy; taxane induced myalgias; electro-acupuncture

Outcome Measures

Primary Outcomes (1)

• Change in Brief Pain Inventory-Short Form Score

  The change in neuropathic pain, as measured by the mean Brief Pain Inventory-Short Form (BPI-SF) worst pain score, from baseline to 16 weeks, in the study group that received electro-acupuncture (intervention), was compared to the change in neuropathic pain in the study group that received sham acupuncture (control). Scores range from 0 (no pain)-10 (worst pain) with a higher score indicating worse outcome.

  Baseline, 16 weeks

Secondary Outcomes (1)

• Change in FACT-TAX Score

  Baseline, 16 weeks

Study Arms (2)

Electro-acupuncture

EXPERIMENTAL

Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.

Device: Electro-acupuncture

Sham acupuncture

SHAM COMPARATOR

Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with sham acupuncture.

Device: Sham acupuncture

Interventions

Electro-acupuncture DEVICE

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.

Electro-acupuncture

Sham acupuncture DEVICE

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.

Sham acupuncture

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>21 years
• History of stage I-III breast cancer
• Patient scheduled to be receiving weekly adjuvant or neo-adjuvant paclitaxel for 12 weeks
• Signed informed consent

You may not qualify if:

• Previous treatment with acupuncture in the last 12 months
• Diabetic Neuropathy or other neurological conditions
• Inflammatory, metabolic or neuropathic arthropathies
• Current narcotic use
• Severe concomitant illnesses
• Severe coagulopathy or bleeding disorder
• Dermatological disease within the acupuncture area
• Have a pacemaker

Sponsors & Collaborators

• Columbia University: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dawn Hershman
• Organization: Columbia University Irving Medical Center

dlh23@cumc.columbia.edu

212-342-5162

Study Officials

• Dawn L Hershman, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine & Epidemiology

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 16, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2017
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-08

Locations

US (1)