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Acupuncture Study for the Prevention of Taxane Induced Myalgias and Neuropathy

This study is currently recruiting participants.
Verified February 2013 by Columbia University
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Dawn L. Hershman, Columbia University
ClinicalTrials.gov Identifier:
NCT01163682
First received: July 14, 2010
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  Purpose

This is a two arm randomized pilot study. This study seeks to determine if 12 weeks of weekly electroacupuncture will prevent or decrease neuropathic pain in breast cancer patients receiving 12 weekly treatments of taxane treatment.


Condition Intervention Phase
Taxane Induced Neuropathy
Breast Cancer
 Other: Electro-acupuncture
Other: Sham acupuncture
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Compare the difference in neuropathic pain between the two arms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Neuropathic pain as measured by the mean Brief Pain Inventory-Short Form (BPI-SF) worst pain score, which will be administered at study entry, 6 weeks, 12 weeks, and 16 weeks


Secondary Outcome Measures:
  • Compare the difference of fact-taxane scores and quality of life measures between the groups [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    FACT-Tax quality of life assessment will be administered at study entry, 6 weeks, 12 weeks, and 16 weeks.

  • Compare the extent of neurologic dysfunction between the two arms [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Neurologic dysfunction will be assessed via the Grooved Pegboard test, which will be administered at study entry, 6 weeks, 12 weeks and 16 weeks.

  • Compare differences in change in pro-inflammatory cytokines [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Blood draw for assays of interleukin 1 beta (IL-1 beta), interleukin 6 (IL-6), and tumor necrosis factor alpha (TNF-alpha) taken at study entry, 6 weeks, 12 weeks, and 16 weeks


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Electro-acupuncture
45 minute sessions scheduled once a week for 12 weeks.
 Other: 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.
Sham Comparator: Sham acupuncture
45 minute sessions scheduled once a week for 12 weeks
 Other: 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 elecrto-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.

Detailed Description:

The primary endpoint of this study is to compare the difference in neuropathic pain as measured by the mean Brief Pain Inventory-Short Form (BPI-SF) worse pain score at 12 weeks between the two arms. The Brief Pain Inventory-Short Form is a well validated clinical tool used frequently to assess severity of pain and its effect on daily functions. BPI-SF also monitors the effects of treatment on pain in patients with cancer and other chronic illnesses. The instrument gives several ratings of the intensity and severity of pain and the degree of pain interference on activity, mood, sleep, relations with others and work. The questionnaire uses a 0-10 scale for subject ratings and takes five minutes to complete. We consider a reduction of 2 or more points on the BPI-SF worst pain item to correspond with a clinically meaningful decrease in pain.

The secondary endpoints include other efficacy outcomes such as quality of life measures, extent of neurological dysfunction, blood levels of pro-inflammatory cytokines, and adverse events.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous treatment with acupuncture
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163682

Contacts
Contact: Herbert Irving Comprehensive Cancer Center Clinical Research Management Office 212-305-8615

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Dawn L Hershman, MD, MS            
Sub-Investigator: Jillian Capodice, MS, L.Ac            
Sub-Investigator: Katherine Crew, MD            
Sub-Investigator: Matthew Maurer, MD            
Sub-Investigator: Kevin Kalinsky, MD            
Sponsors and Collaborators
Columbia University
Breast Cancer Research Foundation
Investigators
Principal Investigator: Dawn L Hershman, MD, MS Columbia University
  More Information

No publications provided

Responsible Party: Dawn L. Hershman, Associate Professor of Medicine & Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT01163682     History of Changes
Other Study ID Numbers: AAAE7054
Study First Received: July 14, 2010
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 23, 2013