NCT02754752

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

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
• Stage III Breast Cancer AJCC v7
• Stage IIIA Breast Cancer AJCC v7
• Stage IIIB Breast Cancer AJCC v7
• Stage IIIC Breast Cancer AJCC v7

Interventions

Type	Name	Description
PROCEDURE	Electroacupuncture Therapy	Undergo electroacupuncture therapy
PROCEDURE	Electroacupuncture Therapy	Undergo modified electroacupuncture therapy
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2016-09-13
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2016-04-28
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study