Acupuncture Study for the Prevention of Taxane Induced Myalgias and Neuropathy
Other: Sham acupuncture
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy|
- Difference in neuropathic pain between the two arms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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
- Difference of fact-taxane scores and quality of life measures between the groups [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]FACT-Tax quality of life assessment will be administered at study entry, 6 weeks, 12 weeks, and 16 weeks.
- Difference of the extent of neurologic dysfunction between the two arms [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Neurologic dysfunction will be assessed via the Grooved Pegboard test, which will be administered at study entry, 6 weeks, 12 weeks and 16 weeks.
- Difference in change in pro-inflammatory cytokines [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Blood draw for assays of interleukin 1 beta (IL-1 beta), interleukin 6 (IL-6), and tumor necrosis factor alpha (TNF-alpha) taken at study entry, 6 weeks, 12 weeks, and 16 weeks
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Electro-acupuncture
45 minute sessions scheduled once a week for 12 weeks.
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
45 minute sessions scheduled once a week for 12 weeks
Other: 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 elecrto-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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163682
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Dawn L Hershman, MD, MS||Columbia University|