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

Not Applicable

Completed

• Conditions: Breast Cancer; Neuropathy
• Interventions: Device: Electro-acupuncture; Device: Sham acupuncture

• Registration Number: NCT01163682
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-16
• Study Start: 2010-12
• Primary Completion: 2015-12
• Study Completion: 2017-05
• Results First Submitted: 2017-06-15
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-28
• Last Update Submitted: 2023-08-28
• Results First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electro-acupuncture	Electro-acupuncture	Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.
Sham acupuncture	Sham acupuncture	Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with sham acupuncture.

Primary Outcome Measures

Name	Time	Method
Change in Brief Pain Inventory-Short Form Score	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

Name	Time	Method
Change in FACT-TAX Score	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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States