Electroacupuncture Therapy in Reducing Chronic Pain in Patients After Breast Cancer Treatment

Study Overview
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Brief Summary
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This randomized phase II trial studies how well electroacupuncture therapy works in reducing chronic pain in patients following surgery for stage I-III breast cancer. Electroacupuncture therapy is a type of complementary integrative medicine in which pulses of weak electrical current are sent through very thin, solid, sterile, stainless steel needles into certain points in the skin. Electroacupuncture therapy may help to lower pain and other surgery-related symptoms.

Detailed Description
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PRIMARY OBJECTIVE: I. Determine the initial efficacy of electroacupuncture (EA) in reducing chronic pain in women following treatment for breast cancer. SECONDARY OBJECTIVES: I. Determine if EA produces greater improvement in physical functional mobility as compared to sham electroacupuncture (SEA) or waitlist control (WLC)s. II. Determine if EA produces greater improvement in overall quality of life (QOL) and symptoms related to fatigue, sleep and mood disturbance compared to SEA or WLC. III. Determine if EA produces lower pain vigilance and awareness as compared to SEA or WLC. IV. Examine the association between baseline expectancy and outcomes. V. Explore associations between response to acupuncture and biologic measures, including 1) single nucleotide polymorphisms (SNPS) in catechol-O- methyltransferase (COMT) and opioid receptor-mu1 (OPRM1), and 2) autotaxin (ATX)/lysophosphatidic acid (LPA) axis. VI. Explore if EA reduces emotional, financial, and behavioral concerns among patients and caregivers compared to the SEA or WLC. OUTLINE: Patients are randomized to 1 of 3 groups. GROUP I (EA): Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. GROUP II (SEA): Patients undergo modified electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Acupuncture needles are placed in different locations using a different technique than those used for Group I. GROUP III (WLC): Patients receive standard of care without any kind of acupuncture therapy. After completion of study treatment, patients are followed up at 4 weeks.

Official Title
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Randomized-Controlled Trial of Acupuncture for Chronic Pain After Breast Cancer Treatment

Conditions
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Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7

Intervention / Treatment
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* Procedure: Electroacupuncture Therapy
* Procedure: Electroacupuncture Therapy
* Other: Laboratory Biomarker Analysis
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be adult women >/= 18 years of age. Be able to read, write, and speak English Able to give informed consent Have a history of stage I, II, or III breast cancer Have a documented visit with an oncologist during the previous 12-months Have no current evidence of disease Have persistent pain (unrelated to aromatase inhibitors or chemotherapy-induced peripheral neuropathy) for at least 3 months following treatment for breast cancer Have pain severity (arithmetic mean of four pain severity items) >= 2 on Brief Pain Inventory (BPI) Have worst pain >= to 4 (0-10 numeric rating scale [NRS]) in the preceding week Be willing and able to adhere to all study-related procedures Have completed all cancer treatment (including surgery, chemotherapy and/or radiation) at least 4 months prior to enrollment Have documented lab work with absolute neutrophil count (ANC) >= 1.0 K/uL and platelets >= 50 K/uL in the past 12 months If applicable, maintain self-management of lymphedema symptoms being performed at home at time of study entry Exclusion Criteria: Metastatic breast cancer (stage IV) Known bleeding disorder per patient reported history Cardiac pacemaker or other implanted electronic devices New or planned new lymphedema treatment during the study period Currently receiving or ever received acupuncture for present pain condition Received acupuncture with electrical stimulation for any condition Received acupuncture for any condition in the past year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (electroacupuncture therapy)<br>Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. | Procedure: Electroacupuncture Therapy<br>* Undergo electroacupuncture therapy<br>* Other names: Electroacupuncture;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Placebo Comparator: Group II (sham electroacupuncture therapy)<br>Patients undergo modified electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Acupuncture needles are placed in different locations using a different technique than those used for Group I. | Procedure: Electroacupuncture Therapy<br>* Undergo modified electroacupuncture therapy<br>* Other names: Electroacupuncture;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group III (waitlist control)<br>Patients receive standard of care without any kind of acupuncture therapy. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain scores assessed by Brief Pain Inventory (BPI) | Change in pain scores will be compared between groups. Assessing the initial efficacy of electroacupuncture (EA) relative to sham electroacupuncture (SEA) and waitlist control (WLC), use linear regression and linear mixed model analyses. Pain Scores(0-10) 0 No pain-10 Worst Pain. | Baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of single nucleotide polymorphisms (SNPs) in (COMT) catechol-O- methyltransferase | Will explore the correlations between response to acupuncture and presence of different gene variations in (COMT) catechol-O- methyltransferase and (OPRM1). Will use linear regression and linear mixed model analyses. | Up to 8 weeks | 
| Presence of single nucleotide polymorphisms (SNPs) in (OPRM1) opioid receptor-mu1 | Will explore correlations between response to acupuncture and presence of different gene variations in (COMT) catechol-O- methyltransferase and (OPRM1) opioid receptor-mu1. Will use linear regression and linear mixed model analyses. | Up to 8 weeks | 
| Change in autotaxin (ATX)/lysophosphatidic acid (LPA) axis | Will explore correlations between response to acupuncture and ATX-mediated LPA biosynthesis. Will use linear regression and linear mixed model analyses. | Baseline to 8 weeks | 
| Spouse Behavior Subscale of the Multidimensional Pain Inventory (SBS-MPI) Questionnaire | Emotional, financial, and behavioral concerns among patients and caregivers will be compared between (EA) electroacupuncture and (SEA) sham electroacupuncture or (WLC) waitlist control group. (Agree or Disagree 5-1) 1-Strongly Disagree, 2-Disagree, 3-Neither agree or Disagree, 4-Agree 5-Strongly Agree | Up to 8 weeks | 
| Caregiver Reaction Assessment (CRA) Questionnaire | Emotional, financial, and behavioral concerns among patients and caregivers will be compared between (EA) electroacupuncture and (SEA) sham electroacupuncture or (WLC) waitlist control group. (Agree or Disagree 5-1) 1-Strongly Disagree, 2-Disagree, 3-Neither agree or Disagree, 4-Agree 5-Strongly Agree | Up to 8 weeks | 
| Baseline expectancy of participants will be correlated to the outcomes response. | Will use linear regression and linear mixed model analyses. | At baseline | 
| Physical functional mobility will be compared. | Change in physical functional mobility will be compared between groups. Assessing the initial efficacy of (EA) electroacupuncture relative to (SEA) sham electroacupuncture and (WLC) waitlist control group., use linear regression and linear mixed model analyses. | Baseline to 8 weeks | 
| Quality of life (QOL) questionnaire | Change in overall (QOL) Quality of life will be compared between groups. Assessing the initial efficacy of (EA) electroacupuncture relative to (SEA) sham electroacupuncture and (WLC) waitlist control group., use linear regression and linear mixed model analyses. | Baseline to 8 weeks | 
| Changes in symptoms of fatigue questionnaire | Changes in symptoms of fatigue, sleep, and mood disturbance will be compared between groups. Assessing the initial efficacy of (EA) electroacupuncture (SEA) sham electroacupuncture and (WLC) waitlist control group., use linear regression and linear mixed mode Fatigue (0-10) 0 No Fatigue-10 Fatigue | Baseline to 8 weeks | 
| Changes in symptoms of sleep questionnaire | Changes in symptoms of fatigue, sleep, and mood disturbance will be compared between groups. Assessing the initial efficacy of (EA) electroacupuncture (SEA) sham electroacupuncture and (WLC) waitlist control group., use linear regression and linear mixed mode. Thee Pittsburgh Sleep Quality Index (PSQI) Very Good (0) Fairly Good (1) Fairly Bad(2) Very Bad (3) | Baseline to 8 weeks | 
| Changes in symptoms of mood disturbance | Changes in symptoms of fatigue, sleep, and mood disturbance will be compared between groups. Assessing the initial efficacy of (EA) electroacupuncture (SEA) sham electroacupuncture and (WLC) waitlist control group., use linear regression and linear mixed mode. Mood (0-10) 0 Does not interfere, 10 Completely Interferes. | Baseline to 8 weeks |