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

Stage IIIC Breast Cancer AJCC v7 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02754752
• Other study ID #: 2015-0750
• Secondary ID: NCI-2016-0079220
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 13, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 111
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Chronic Pain
• 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

Intervention

Procedure:
• Electroacupuncture Therapy
Undergo electroacupuncture therapy
• Electroacupuncture Therapy
Undergo modified electroacupuncture therapy

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Gateway for Cancer Research, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 8 weeks
Secondary	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.	Up to 8 weeks
Secondary	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.	Up to 8 weeks
Secondary	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.	Baseline to 8 weeks
Secondary	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	Up to 8 weeks
Secondary	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	Up to 8 weeks
Secondary	Baseline expectancy of participants will be correlated to the outcomes response.	Will use linear regression and linear mixed model analyses.	At baseline
Secondary	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.	Baseline to 8 weeks
Secondary	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.	Baseline to 8 weeks
Secondary	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	Baseline to 8 weeks
Secondary	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)	Baseline to 8 weeks
Secondary	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.	Baseline to 8 weeks

External Links

•   University of Texas MD Anderson Cancer Center Website