Stage I Breast Cancer AJCC v7Phase 2NCT02754752

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

A Phase 2 study testing Electroacupuncture Therapy, Laboratory Biomarker Analysis and Quality-of-Life Assessment in people with Stage I Breast Cancer AJCC v7 and Stage IA Breast Cancer AJCC v7, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7
What is being tested?: Electroacupuncture Therapy, Laboratory Biomarker Analysis and Quality-of-Life Assessment
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 111 participants
Where: 1 siteUnited States
Study dates: 13 Sep 2016to 31 Dec 2026
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 13Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

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

Read the detailed description

PRIMARY OBJECTIVE:

Determine the initial efficacy of electroacupuncture (EA) in reducing chronic pain in women following treatment for breast cancer.

SECONDARY OBJECTIVES:

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: 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
Being tested: Electroacupuncture Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electroacupuncture TherapyProcedure or surgery
Also called Electroacupuncture
Undergo electroacupuncture therapy
Electroacupuncture TherapyProcedure or surgery
Also called Electroacupuncture
Undergo modified electroacupuncture therapy
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT02754752
Study group	Role	What they receive
Group I (electroacupuncture therapy)	Experimental	Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Receives: Procedure: Electroacupuncture Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group II (sham electroacupuncture therapy)	Placebo comparator	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. Receives: Procedure: Electroacupuncture Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Group III (waitlist control)	Active comparator	Patients receive standard of care without any kind of acupuncture therapy. Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 8 weeks

Secondary outcomes (11)

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to 8 weeks
Baseline expectancy of participants will be correlated to the outcomes response.
Will use linear regression and linear mixed model analyses.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: Baseline to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Sep 201631 Dec 2026

First posted28 Apr 2016 (estimated)
Study start13 Sep 2016
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stage I Breast Cancer AJCC v7Studies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02754752
Sponsor's protocol ID: 2015-0750
Other IDs: NCI-2016-00792, 2015-0750
Status last verified: Oct 2026
First submitted: 26 Apr 2016
Last updated: 9 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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