Clinical trial NCT03697200: Auricular Point Acupressure to Self-Manage Chronic Pain or Aromatase Inhibitor Musculoskeletal Symptoms in Breast Cancer Survivors: Effectiveness and Scientific Underpinnings
Official title: Auricular Point Acupressure to Self-Manage Chronic Pain or Aromatase Inhibitor Musculoskeletal Symptoms in Breast Cancer Survivors: Effectiveness and Scientific Underpinnings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aromatase Inhibitor
Musculoskeletal Symptoms
Postmenopausal Breast Cancer Survivors
Keywords: Breast Cancer Survivors
Aromatase Inhibitor
Ecological Momentary Assessment
Musculoskeletal Symptoms
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Aromatase inhibitor therapy has become a standard adjuvant endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer. Up to 50% of postmenopausal breast cancer survivors exhibit significant aromatase inhibitor musculoskeletal symptoms, defined as severe joint pain and stiffness. Aromatase inhibitor musculoskeletal symptoms in turn has a negative effect on the women's physical function and quality of life, leading to discontinued aromatase inhibitor therapy and causing significant social and economic burden. Given aromatase inhibitor musculoskeletal symptoms' profound effects, the management of aromatase inhibitor musculoskeletal symptoms is an essential component in cancer care.

The investigators propose to test auricular point acupressure- -an innovative, non-invasive, nonpharmacologic, and low-cost intervention- -to manage aromatase inhibitor musculoskeletal symptoms in breast cancer survivors. Auricular point acupressure applies an acupuncture-like stimulation to ear acupoints without using a needle (i.e., seeds are taped to the acupoints) to treat illness/symptoms. Auricular point acupressure is particularly well suited for current challenges of unmet aromatase inhibitor musculoskeletal symptoms management. The investigators propose a randomized controlled trial to (1) determine the efficacy of auricular point acupressure in relieving aromatase inhibitor musculoskeletal symptoms, and (2) examine the inflammatory signaling of auricular point acupressure effects in breast cancer survivors treated with aromatase inhibitor. The investigators will also measure psychological, behavioral, personal, and social factors that may moderate or mediate the effects of auricular point acupressure. The investigators also believe inflammatory cytokines may partially explain the mechanism of action of auricular point acupressure for improved aromatase inhibitor musculoskeletal symptoms and physical function, and plan to measure these.

This study will identify a novel approach to manage aromatase inhibitor musculoskeletal symptoms in postmenopausal breast cancer survivors, with minimal side effects. If successful, the paradigm of pain management will shift from a traditional medical model to a larger integrative medicine and patient-management paradigm to avoid unnecessary evolution towards prolonged disability.


Eligibility criteria: Inclusion Criteria:

* Women with a history of Breast Cancer (non-metastatic) before entering into postmenopausal age
* Currently receiving AIs (anastrazole, letrozole, exemestane) per chart documentation for at least 2 months (the peak onset of AIMSS is 1.6 months).
* Able to read and write English
* Have joint pain attributable to AI-or had pre-existing joint pain that worsened after the initiation of AIs-and had worst joint pain rated as 4 or more on a 0-10 numeric rating scale in the previous week
* Are willing to commit to weekly study visits for 4 weeks during the intervention and monthly follow-up visits for 3 months (up to 4 months)
* Able to apply pressure to the seeds taped to the ears

Exclusion Criteria:

* Metastatic breast cancer
* Completed cytotoxic chemotherapy or radiation therapy less than 4 weeks prior to enrollment (because chemotherapy and radiation therapy can cause temporary exacerbation of joint symptoms that typically resolve spontaneously)
* Bone fracture/surgery of an affiliated extremity during the preceding 6 months
* Current use of corticosteroids or narcotics
* Ear skin disease
* Allergy to the tape used for this study
* Having had previous auricular therapy (because they would be unable to be blinded for the study)
* Having been hospitalized for mental health reasons within the last 3 months
* Piercings on the ear points for treatment

Primary outcomes:
measure: Change in Pain Intensity as assessed by the Brief Pain Inventory-short form
timeFrame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks)
measure: Change in Physical Function as assessed by the Western Ontario and McMaster Osteoarthritis Index
timeFrame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks)
measure: Change in Physical disability as assessed by the QuickDASH
timeFrame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks)
measure: Change in Physical Strength as assessed by Handgrip
timeFrame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks)
Secondary outcomes:
measure: Change in medication use adherence as assessed by the Ecological Momentary Assessment
timeFrame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Chao H Yeh, PhD
role: PRINCIPAL_INVESTIGATOR
References: