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

M.D. Anderson Cancer Center

Status and phase: Active, not recruiting; Phase 2

Conditions: Stage IIB Breast Cancer AJCC V6 and V7; Stage IIIC Breast Cancer AJCC V7; Stage IIA Breast Cancer AJCC V6 and V7; Stage II Breast Cancer AJCC V6 and V7; Stage IIIB Breast Cancer AJCC V7; Stage III Breast Cancer AJCC V7; Stage IA Breast Cancer AJCC V7; Stage IB Breast Cancer AJCC V7; Stage I Breast Cancer AJCC V7; Stage IIIA Breast Cancer AJCC V7

Treatments: Procedure: Electroacupuncture Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02754752

2015-0750 (Other Identifier)

NCI-2016-00792 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

111 participants in 3 patient groups, including a placebo group

Group I (electroacupuncture therapy)

Experimental group

Description:

Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions.

Treatment:

Procedure: Electroacupuncture Therapy

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Procedure: Electroacupuncture Therapy

Group II (sham electroacupuncture therapy)

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Electroacupuncture Therapy

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Procedure: Electroacupuncture Therapy

Group III (waitlist control)

Active Comparator group

Description:

Patients receive standard of care without any kind of acupuncture therapy.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Questionnaire Administration

Other: Quality-of-Life Assessment