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Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy


Phase 1
21 Years
N/A
Open (Enrolling)
Female
Taxane Induced Neuropathy, Breast Cancer

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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 CenterNew York, New York  10032