Electroacupuncture Therapy in Reducing Chronic Pain in Patients After Breast Cancer Treatment
NCT ID: NCT02754752
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
111 participants
INTERVENTIONAL
2016-09-13
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Group I (electroacupuncture therapy)
Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions.
Electroacupuncture Therapy
Undergo electroacupuncture therapy
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Group II (sham 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.
Electroacupuncture Therapy
Undergo modified electroacupuncture therapy
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Group III (waitlist control)
Patients receive standard of care without any kind of acupuncture therapy.
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Electroacupuncture Therapy
Undergo electroacupuncture therapy
Electroacupuncture Therapy
Undergo modified electroacupuncture therapy
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Gateway for Cancer Research
OTHER
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lorenzo Cohen
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2016-00792
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-0750
Identifier Type: OTHER
Identifier Source: secondary_id
2015-0750
Identifier Type: -
Identifier Source: org_study_id
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