Electroacupuncture Therapy in Reducing Chronic Pain in Patients After Breast Cancer Treatment
Randomized-Controlled Trial of Acupuncture for Chronic Pain After Breast Cancer Treatment
2 other identifiers
interventional
111
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2016
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedStudy Start
First participant enrolled
September 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 15, 2026
April 1, 2026
10.3 years
April 26, 2016
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Presence of single nucleotide polymorphisms (SNPs) in (COMT) catechol-O- methyltransferase
Up to 8 weeks
Presence of single nucleotide polymorphisms (SNPs) in (OPRM1) opioid receptor-mu1
Up to 8 weeks
Change in autotaxin (ATX)/lysophosphatidic acid (LPA) axis
Baseline to 8 weeks
Spouse Behavior Subscale of the Multidimensional Pain Inventory (SBS-MPI) Questionnaire
Up to 8 weeks
Caregiver Reaction Assessment (CRA) Questionnaire
Up to 8 weeks
- +6 more secondary outcomes
Study Arms (3)
Group I (electroacupuncture therapy)
EXPERIMENTALPatients 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)
PLACEBO COMPARATORPatients 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)
ACTIVE COMPARATORPatients receive standard of care without any kind of acupuncture therapy.
Interventions
Undergo electroacupuncture therapy
Correlative studies
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Gateway for Cancer Researchcollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorenzo Cohen
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2016
First Posted
April 28, 2016
Study Start
September 13, 2016
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04