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

March 28, 2024 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Procedure: Electroacupuncture Therapy
Undergo electroacupuncture therapy
Other Names:
  • Electroacupuncture
Procedure: Electroacupuncture Therapy
Undergo modified electroacupuncture therapy
Other Names:
  • Electroacupuncture
Placebo Comparator: 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.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Procedure: Electroacupuncture Therapy
Undergo electroacupuncture therapy
Other Names:
  • Electroacupuncture
Procedure: Electroacupuncture Therapy
Undergo modified electroacupuncture therapy
Other Names:
  • Electroacupuncture
Active Comparator: Group III (waitlist control)
Patients receive standard of care without any kind of acupuncture therapy.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain scores assessed by Brief Pain Inventory (BPI)
Time Frame: 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.
Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of single nucleotide polymorphisms (SNPs) in (COMT) catechol-O- methyltransferase
Time Frame: 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.
Up to 8 weeks
Presence of single nucleotide polymorphisms (SNPs) in (OPRM1) opioid receptor-mu1
Time Frame: 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.
Up to 8 weeks
Change in autotaxin (ATX)/lysophosphatidic acid (LPA) axis
Time Frame: 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.
Baseline to 8 weeks
Spouse Behavior Subscale of the Multidimensional Pain Inventory (SBS-MPI) Questionnaire
Time Frame: 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
Up to 8 weeks
Caregiver Reaction Assessment (CRA) Questionnaire
Time Frame: 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
Up to 8 weeks
Baseline expectancy of participants will be correlated to the outcomes response.
Time Frame: At baseline
Will use linear regression and linear mixed model analyses.
At baseline
Physical functional mobility will be compared.
Time Frame: 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.
Baseline to 8 weeks
Quality of life (QOL) questionnaire
Time Frame: 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.
Baseline to 8 weeks
Changes in symptoms of fatigue questionnaire
Time Frame: 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
Baseline to 8 weeks
Changes in symptoms of sleep questionnaire
Time Frame: 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)
Baseline to 8 weeks
Changes in symptoms of mood disturbance
Time Frame: 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.
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)
Gateway for Cancer Research

Investigators

  • Principal Investigator: Lorenzo Cohen, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2016

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimated)

April 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0750 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2016-00792 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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