Clinical trial NCT02754752: Electroacupuncture Therapy in Reducing Chronic Pain in Patients After Breast Cancer Treatment
Official title: Randomized-Controlled Trial of Acupuncture for Chronic Pain After Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Gateway for Cancer Research
name: National Cancer Institute (NCI)
First posted: 2016-04-28
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain scores assessed by Brief Pain Inventory (BPI)
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Presence of single nucleotide polymorphisms (SNPs) in (COMT) catechol-O- methyltransferase
timeFrame: Up to 8 weeks
measure: Presence of single nucleotide polymorphisms (SNPs) in (OPRM1) opioid receptor-mu1
timeFrame: Up to 8 weeks
measure: Change in autotaxin (ATX)/lysophosphatidic acid (LPA) axis
timeFrame: Baseline to 8 weeks
measure: Spouse Behavior Subscale of the Multidimensional Pain Inventory (SBS-MPI) Questionnaire
timeFrame: Up to 8 weeks
measure: Caregiver Reaction Assessment (CRA) Questionnaire
timeFrame: Up to 8 weeks
measure: Baseline expectancy of participants will be correlated to the outcomes response.
timeFrame: At baseline
measure: Physical functional mobility will be compared.
timeFrame: Baseline to 8 weeks
measure: Quality of life (QOL) questionnaire
timeFrame: Baseline to 8 weeks
measure: Changes in symptoms of fatigue questionnaire
timeFrame: Baseline to 8 weeks
measure: Changes in symptoms of sleep questionnaire
timeFrame: Baseline to 8 weeks
measure: Changes in symptoms of mood disturbance
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorenzo Cohen
role: PRINCIPAL_INVESTIGATOR
References: