Electroacupuncture Therapy in Reducing Chronic Pain in Patients After Breast Cancer Treatment
- Conditions
- Stage I Breast Cancer AJCC v7Stage IA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7Stage II Breast Cancer AJCC v6 and v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7Stage III Breast Cancer AJCC v7Stage IIIA Breast Cancer AJCC v7Stage IIIB Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7
- Interventions
- Procedure: Electroacupuncture TherapyOther: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentOther: Questionnaire Administration
- Registration Number
- NCT02754752
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 111
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group II (sham electroacupuncture therapy) Electroacupuncture Therapy 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 (waitlist control) Laboratory Biomarker Analysis Patients receive standard of care without any kind of acupuncture therapy. Group I (electroacupuncture therapy) Electroacupuncture Therapy Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Group I (electroacupuncture therapy) Questionnaire Administration Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Group II (sham electroacupuncture therapy) Questionnaire Administration 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 I (electroacupuncture therapy) Laboratory Biomarker Analysis Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Group II (sham electroacupuncture therapy) Laboratory Biomarker Analysis 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 I (electroacupuncture therapy) Quality-of-Life Assessment Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Group II (sham electroacupuncture therapy) Quality-of-Life Assessment 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 (waitlist control) Quality-of-Life Assessment Patients receive standard of care without any kind of acupuncture therapy. Group III (waitlist control) Questionnaire Administration Patients receive standard of care without any kind of acupuncture therapy.
- Primary Outcome Measures
Name Time Method Change in pain scores assessed by Brief Pain Inventory (BPI) Baseline to 8 weeks 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.
- Secondary Outcome Measures
Name Time Method Presence of single nucleotide polymorphisms (SNPs) in (COMT) catechol-O- methyltransferase Up to 8 weeks 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.
Change in autotaxin (ATX)/lysophosphatidic acid (LPA) axis Baseline to 8 weeks Will explore correlations between response to acupuncture and ATX-mediated LPA biosynthesis. Will use linear regression and linear mixed model analyses.
Caregiver Reaction Assessment (CRA) Questionnaire Up to 8 weeks 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
Changes in symptoms of fatigue questionnaire Baseline to 8 weeks 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
Changes in symptoms of sleep questionnaire Baseline to 8 weeks 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)
Presence of single nucleotide polymorphisms (SNPs) in (OPRM1) opioid receptor-mu1 Up to 8 weeks 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.
Spouse Behavior Subscale of the Multidimensional Pain Inventory (SBS-MPI) Questionnaire Up to 8 weeks 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
Baseline expectancy of participants will be correlated to the outcomes response. At baseline Will use linear regression and linear mixed model analyses.
Physical functional mobility will be compared. Baseline to 8 weeks 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.
Quality of life (QOL) questionnaire Baseline to 8 weeks 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.
Changes in symptoms of mood disturbance Baseline to 8 weeks 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.
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States