NCT01050075

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	acupuncture therapy	acupuncture therapy
OTHER	questionnaire administration	Ancillary study
OTHER	management of therapy complications	To be determined by the treating physician

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-01-15
• Last updated: 2017-11-06

Locations

2 sites across 1 country: United States