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



Status:Terminated
Conditions:Breast Cancer, Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/8/2017
Start Date:January 2010
End Date:May 2012

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A Pilot Study Investigating the Feasibility of Using Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy

RATIONALE: Acupuncture may help relieve nerve pain caused by chemotherapy.

PURPOSE: This randomized clinical trial is studying how well acupuncture works in treating
nerve pain in patients with stage I, stage II, and 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
We found this trial at
2
sites
Pasadena, California 91105
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Pasadena, CA
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Duarte, California 91010
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Duarte, CA
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