Acupuncture in Treating Nerve Pain in Patients With Stage I, Stage II, or Stage III Breast Cancer Who Are Receiving Paclitaxel

PRIMARY OBJECTIVE:

I. To explore the potential for the use of acupuncture to prevent a worsening of the nerve
damage in patients (during treatment) due to paclitaxel as measured by a Neuropathic Pain
Symptom Inventory.

SECONDARY OBJECTIVES:

I. Evaluate the impact of acupuncture based on neurological assessment, quantitative sensory
tests and nerve conduction tests.

II. Evaluate the improvement observed when treating patients for peripheral neuropathy
(post-chemotherapy) with acupuncture based on the same metrics.

III. To correlate objective measures of neuropathy (nerve conduction, quantitative sensory
tests, neuropathy composite score, and blood cytokine levels) with the subjective
questionnaire/quality of life measures.

OUTLINE:

Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel every 2 weeks for 4 courses as standard of care. Patients
undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses
3 and 4.

ARM II: Patients receive paclitaxel every 2 weeks for 4 courses as standard of care. Patients
then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.

Inclusion

- Patients must have a history of histologically or cytologically confirmed stage I, II,
or III breast cancer that have received 2 cycles of paclitaxel, and expected to
receive paclitaxel for two more cycles, and are experiencing grade 1 peripheral
neuropathy (CTCAE criteria)

- Performance ECOG 0-2 (Karnofsky Performance Status >= 60%)

- Life expectancy of greater than 6 months

- Ability to understand and the willingness to sign a written informed consent document

Exclusion

- Patients with radiologically confirmed stage IV breast cancer

- Patients who had acupuncture in the previous 8 weeks

- Change in use of any of the following drugs in the prior 4 weeks: opiates,
antidepressants, or anxiolytics ("change" is defined as initiation or cessation of
treatment, or change in prescribed dose or regimen)

- Patients with needle phobia

- Patients who experienced any peripheral neuropathy prior to chemotherapy

- Patients who have the potential for serious bleeding due to inherited diseases such as
hemophilia

- Patients with diabetes