Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
21 Years
N/A
Female
Taxane Induced Neuropathy, Breast Cancer
Trial Information
Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
The primary endpoint of this study is to compare the difference in neuropathic pain as
measured by the mean Brief Pain Inventory-Short Form (BPI-SF) worse pain score at 12 weeks
between the two arms. The Brief Pain Inventory-Short Form is a well validated clinical tool
used frequently to assess severity of pain and its effect on daily functions. BPI-SF also
monitors the effects of treatment on pain in patients with cancer and other chronic
illnesses. The instrument gives several ratings of the intensity and severity of pain and
the degree of pain interference on activity, mood, sleep, relations with others and work.
The questionnaire uses a 0-10 scale for subject ratings and takes five minutes to complete.
We consider a reduction of 2 or more points on the BPI-SF worst pain item to correspond with
a clinically meaningful decrease in pain.
The secondary endpoints include other efficacy outcomes such as quality of life measures,
extent of neurological dysfunction, blood levels of pro-inflammatory cytokines, and adverse
events.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
Compare the difference in neuropathic pain between the two arms
Outcome Description:
Neuropathic pain as measured by the mean Brief Pain Inventory-Short Form (BPI-SF) worst pain score, which will be administered at study entry, 6 weeks, 12 weeks, and 16 weeks
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Dawn L Hershman, MD, MS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Columbia University
Authority:
United States: Institutional Review Board
Study ID:
AAAE7054
NCT ID:
NCT01163682
Start Date:
May 2010
Completion Date:
December 2013
Related Keywords:
- Taxane Induced Neuropathy
- Breast Cancer
- Breast Neoplasms
- Demyelinating Diseases
- Polyneuropathies
- Nerve Compression Syndromes
- Neurologic Manifestations
- Neurotoxicity Syndromes
Name | Location |
|---|---|
| Columbia University Medical Center | New York, New York 10032 |
