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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    109
  • sponsor
    M.D. Anderson Cancer Center
Updated on 23 February 2022
cancer
absolute neutrophil count
chronic pain
weak
neutrophil count
cancer treatment
aromatase inhibitor
aromatase inhibition therapy

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.

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.

Details
Condition 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, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7
Treatment laboratory biomarker analysis, questionnaire administration, quality-of-life assessment, Questionnaires, Standard of Care, Electro-acupuncture, Sham Electro-Acupuncture, Electroacupuncture Therapy, Electroacupuncture Therapy
Clinical Study IdentifierNCT02754752
SponsorM.D. Anderson Cancer Center
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

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
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