- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01163682
Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
August 28, 2023 updated by: Dawn L. Hershman, Columbia University
Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electro-acupuncture
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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Baseline, 16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dawn L Hershman, MD, MS, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2010
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
July 14, 2010
First Submitted That Met QC Criteria
July 14, 2010
First Posted (Estimated)
July 16, 2010
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAE7054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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