A Pilot Study Investigating the Feasibility of Using Acupuncture for the Treatment of Taxane-Induced Peripheral Neuropathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- City of Hope Medical Center
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Change in the Neuropathic Pain Symptom Inventory Scores
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in the Neuropathic Pain Symptom Inventory Scores
Time Frame: At the end of 4 courses of chemotherapy
Secondary Outcomes
- Percentage of patients requiring a dose reduction or additional neuropathy distress related pharmacologic management(Eight weeks after study enrollment)
- Impact of assigning patients the worst score when dose reducing/or prescribing additional treatment(Eight weeks after study enrollment)
- Observed improvement in patients following treatment with acupuncture as to compared to those no longer receiving acupuncture(Eight weeks after study enrollment)
- Comparison of changes in neurological assessment of patients(At the end of therapy and 1 month after the end of therapy)
- Correlation between nerve inventory questionnaires and quantitative nerve tests(Eight weeks after study enrollment)