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

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ClinicalTrials.gov Identifier: NCT01163682
Recruitment Status : Completed
First Posted : July 16, 2010
Results First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Dawn L. Hershman, Columbia University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Neuropathy Device: Electro-acupuncture Device: Sham acupuncture Not Applicable

Detailed Description:
Chemotherapy induced neuropathy (CIN) is a common and disabling toxicity of cytotoxic chemotherapy. Depending on the drug, it is often irreversible even after the offending agent is removed. The consequence of terminating effective anti-tumor therapy or dose reduction can be catastrophic to the effect of a patient's cancer treatment. Given the morbidity of taxane induced neuropathy, the lack of effective preventative treatment for taxane induce neuropathy and the safety of acupuncture, it is reasonable to test the efficacy of this non pharmacological intervention in woman with Stage I-III breast cancer receiving adjuvant or neo-adjuvant weekly paclitaxel for 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
Actual Study Start Date : December 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Electro-acupuncture
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.
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.

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




Primary Outcome Measures :
  1. Change in Brief Pain Inventory-Short Form Score [ Time Frame: Baseline, 16 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in FACT-TAX Score [ Time Frame: Baseline, 16 weeks ]
    The change in the quality of life as measured by Functional Assessment of Cancer Therapy- Taxane (FACT-TAX) quality of life assessment, collected at baseline and 16 weeks, as compared between the intervention and control study groups (electro acupuncture and sham acupuncture). is a validated self reported instrument used to measure self reported neuropathic symptoms among patients undergoing taxane therapy. There are four quality of life (QOL) domains as part of the FACT that include physical well being, social well being, emotional well being and functional well being. The taxane subscale combines a validated 11 item neurotoxicity subscale with 5 additional questions assessing symptoms related to arthralgias, myalgias and skin changes. The FACT-TAX scale ranges from 0-64 with five response levels (0= very much, 4 = not at all). Higher scores indicate better quality of life or fewer symptoms.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes 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 or neo-adjuvant paclitaxel for 12 weeks
  • Signed informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163682


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Breast Cancer Research Foundation
Investigators
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Principal Investigator: Dawn L Hershman, MD, MS Columbia University
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Responsible Party: Dawn L. Hershman, Associate Professor of Medicine & Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT01163682    
Other Study ID Numbers: AAAE7054
First Posted: July 16, 2010    Key Record Dates
Results First Posted: September 21, 2023
Last Update Posted: September 21, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dawn L. Hershman, Columbia University:
taxane induced neuropathy
taxane induced myalgias
electro-acupuncture
Additional relevant MeSH terms:
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Myalgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations