search
Back to results

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

Primary Purpose

Breast Cancer, Neuropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electro-acupuncture
Sham acupuncture
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring taxane induced neuropathy, taxane induced myalgias, electro-acupuncture

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Electro-acupuncture

Sham acupuncture

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in FACT-TAX Score
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.

Full Information

First Posted
July 14, 2010
Last Updated
August 28, 2023
Sponsor
Columbia University
Collaborators
Breast Cancer Research Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT01163682
Brief Title
Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
Official Title
Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Breast Cancer Research Foundation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neuropathy
Keywords
taxane induced neuropathy, taxane induced myalgias, electro-acupuncture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electro-acupuncture
Arm Type
Experimental
Arm Description
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with sham acupuncture.
Intervention Type
Device
Intervention Name(s)
Electro-acupuncture
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham acupuncture
Intervention Description
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 Measure Information:
Title
Change in Brief Pain Inventory-Short Form Score
Description
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.
Time Frame
Baseline, 16 weeks
Secondary Outcome Measure Information:
Title
Change in FACT-TAX Score
Description
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.
Time Frame
Baseline, 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn L Hershman, MD, MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs