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

Not Applicable

Terminated

• Conditions: Breast Cancer; Stage II Breast Cancer; Stage IIIC Breast Cancer; Stage IIIB Breast Cancer; Stage I Breast Cancer; Stage IIIA Breast Cancer
• Interventions: Other: acupuncture therapy; Other: questionnaire administration; Other: management of therapy complications

• Registration Number: NCT01050075
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-14
• Study First Posted: 2010-01-15
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	acupuncture therapy	Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.
Arm I	questionnaire administration	Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.
Arm II	questionnaire administration	Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
Arm II	acupuncture therapy	Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.
Arm I	management of therapy complications	Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks during courses 3 and 4.
Arm II	management of therapy complications	Patients receive paclitaxel as standard of care every 2 weeks for 4 courses. Patients then undergo acupuncture therapy comprising 2 30-minute sessions a week for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in the Neuropathic Pain Symptom Inventory Scores	At the end of 4 courses of chemotherapy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

City of Hope Medical Group Inc; 🇺🇸 Pasadena, California, United States

City of Hope; 🇺🇸 Duarte, California, United States