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

Study 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.

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

Conditions
-----------------
Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Intervention / Treatment
-----------------
* Other: acupuncture therapy
* Other: questionnaire administration
* Other: management of therapy complications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Patients must have a history of histologically or cytologically confirmed stage I, II, or III breast cancer that have received 2 cycles of paclitaxel, and expected to receive paclitaxel for two more cycles, and are experiencing grade 1 peripheral neuropathy (CTCAE criteria) Performance ECOG 0-2 (Karnofsky Performance Status >= 60%) Life expectancy of greater than 6 months Ability to understand and the willingness to sign a written informed consent document Exclusion Patients with radiologically confirmed stage IV breast cancer Patients who had acupuncture in the previous 8 weeks Change in use of any of the following drugs in the prior 4 weeks: opiates, antidepressants, or anxiolytics (change is defined as initiation or cessation of treatment, or change in prescribed dose or regimen) Patients with needle phobia Patients who experienced any peripheral neuropathy prior to chemotherapy Patients who have the potential for serious bleeding due to inherited diseases such as hemophilia Patients with diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Other: acupuncture therapy<br>* acupuncture therapy<br>* Other names: acupuncture;Other: questionnaire administration<br>* Ancillary study<br>Other: management of therapy complications<br>* To be determined by the treating physician<br>* Other names: complications of therapy, management of;|
| Experimental: Arm II<br>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. | Other: acupuncture therapy<br>* acupuncture therapy<br>* Other names: acupuncture;Other: questionnaire administration<br>* Ancillary study<br>Other: management of therapy complications<br>* To be determined by the treating physician<br>* Other names: complications of therapy, management of;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Neuropathic Pain Symptom Inventory Scores |  | At the end of 4 courses of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
male breast cancer, neurotoxicity, recurrent breast cancer