Acupuncture Study for the Prevention of Taxane Induced Myalgias and Neuropathy
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 04/30/2015 |
| First Submitted: | 07/13/2010 |
| Estimated Enrollment Submitted: | 07/13/2010 |
| First Posted: | 07/15/2010 |
| Last Update Submitted: | 05/19/2015 |
| Last Update Posted: | 05/20/2015 |
| Actual Study Start Date: | 11/30/2010 |
| Estimated Primary Completion Date: | 11/30/2015 |
| Estimated Study Completion Date: | 11/30/2015 |
Condition or disease
Intervention/treatment
Other: Electro-acupuncture
Other: Sham acupuncture
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Electro-acupuncture 45 minute sessions scheduled once a week for 12 weeks. | Other: 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 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. |
Eligibility Criteria
| Ages Eligible for Study | 21 Years To 21 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Difference in neuropathic pain between the two arms [12 weeks]
Secondary Outcome Measures
1. Difference of fact-taxane scores and quality of life measures between the groups [16 weeks]
2. Difference of the extent of neurologic dysfunction between the two arms [16 weeks]
3. Difference in change in pro-inflammatory cytokines [16 weeks]
