Breast Cancer Clinical Trial

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

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

7

Study ID:

NCT01050075

Recruitment Status:

Terminated

Sponsor:

City of Hope Medical Center

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There are 2 Locations for this study

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City of Hope
Duarte California, 91010, United States
City of Hope Medical Group Inc
Pasadena California, 91105, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

7

Study ID:

NCT01050075

Recruitment Status:

Terminated

Sponsor:


City of Hope Medical Center

How clear is this clinincal trial information?

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