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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
7
acupuncture therapy
Ancillary study
To be determined by the treating physician
City of Hope
Duarte, California, United States
City of Hope Medical Group Inc
Pasadena, California, United States
Change in the Neuropathic Pain Symptom Inventory Scores
Time frame: At the end of 4 courses of chemotherapy
Percentage of patients requiring a dose reduction or additional neuropathy distress related pharmacologic management
Time frame: Eight weeks after study enrollment
Impact of assigning patients the worst score when dose reducing/or prescribing additional treatment
Time frame: Eight weeks after study enrollment
Observed improvement in patients following treatment with acupuncture as to compared to those no longer receiving acupuncture
Time frame: Eight weeks after study enrollment
Comparison of changes in neurological assessment of patients
Time frame: At the end of therapy and 1 month after the end of therapy
Correlation between nerve inventory questionnaires and quantitative nerve tests
Time frame: Eight weeks after study enrollment
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