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

• 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: Columbia University
• Collaborator: Breast Cancer Research Foundation
• Information provided by (Responsible Party): Dawn L. Hershman, Columbia University

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Dawn L Hershman, MD, MS; Columbia University

More Information

• 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
• 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

• 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:

Myalgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations