This trial is active, not recruiting.

Condition breast cancer
Treatments electro-acupuncture, sham acupuncture
Phase phase 1
Sponsor Columbia University
Collaborator Breast Cancer Research Foundation
Start date December 2010
End date December 2015
Trial size 50 participants
Trial identifier NCT01163682, AAAE7054


This is a two arm randomized pilot study. This study seeks to determine if 12 weeks of weekly electroacupuncture will prevent or decrease neuropathic pain in breast cancer patients receiving 12 weekly treatments of taxane treatment.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
(Active Comparator)
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)
45 minute sessions scheduled once a week for 12 weeks
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.

Primary Outcomes

Difference in neuropathic pain between the two arms
time frame: 12 weeks

Secondary Outcomes

Difference of fact-taxane scores and quality of life measures between the groups
time frame: 16 weeks
Difference of the extent of neurologic dysfunction between the two arms
time frame: 16 weeks
Difference in change in pro-inflammatory cytokines
time frame: 16 weeks

Eligibility Criteria

Female participants at least 21 years old.

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

Additional Information

Official title Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
Principal investigator Dawn L Hershman, MD, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Columbia University.