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

Breast Cancer Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer

• NCT number: NCT01050075
• Study type: Interventional
• Source: City of Hope Medical Center
• Status: Terminated
• Phase: N/A
• Start date: January 2010
• Completion date: May 2012