Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Change in Brief Pain Inventory-Short Form Score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- Change in FACT-TAX Score(Baseline, 16 weeks)
Investigators
Dawn L. Hershman
Associate Professor of Medicine & Epidemiology
Columbia University