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Auricular Point Acupressure to Manage Aromatase Inhibitor Musculoskeletal Symptoms in Postmenopausal Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03697200
Recruitment Status : Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Aromatase Inhibitor Musculoskeletal Symptoms Postmenopausal Breast Cancer Survivors Other: APA Other: Sham APA control Other: Education control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Auricular Point Acupressure to Manage Aromatase Inhibitor Musculoskeletal Symptoms in Postmenopausal Breast Cancer Survivors
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Auricular Point Acupressure (APA)
Patients with active points related to Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS). The points for AIMSS include (1) points corresponding to body pain location and (2) three points known for alleviating stress and pain (i.e., shenmen, sympathetic, and nervous subcortex)
Other: APA
Light touch using vaccaria seeds on specific points of the ear

Sham Comparator: Sham APA control
The same procedure of APA will be applied but the tapes/seeds will be placed on different points (points not related to AIMSS). Participants in the Sham APA Control will receive APA on the five ear points comprising mouth, stomach, duodenum, internal ear, and tonsils. These points are chosen for the Sham APA Control for two reasons: First, they are distinct from the zones of the ear (and the points therein) associated with AIMSS and correspond to body regions in which BCS (Breast Cancer Survivors) are usually pain-free; second, they are equivalent in number to those points used in the APA treatment group and no negative impacts have been observed among these points in our pilot study.
Other: Sham APA control
Light touch using vaccaria seeds on different points of the ear (compared to the APA group).

Education Control
Participants in the Education Control will receive four, 15-minute weekly individual sessions in which the scheduling and duration of interaction with the study staff are identical to the APA and Sham interventions. Educational sessions are intended to reflect usual standard medical care per guidelines from the American Society of Clinical Oncology (ASCO), while also meeting the needs of trial participation, including (1) the knowledge of hormonal therapy and side effects; (2) assessment and management of physical long-term and late effects; (3) assessment and management of psychological long-term and late effects; and (4) dietary (developed by Co-I, van Londen) and physical activity in Breast Cancer Survivors (BCS) (developed by Co-I, Stearns). These materials have been used by the research team, and clinical practice. Materials will be tailored so that they can be delivered within 15 minutes for each session.
Other: Education control
Participants in the Education Control will receive four, 15-minute weekly individual sessions in which the scheduling and duration of interaction with the study staff are identical to the APA and Sham interventions. Materials will be tailored so that they can be delivered within 15 minutes for each session




Primary Outcome Measures :
  1. Change in Pain Intensity as assessed by the Brief Pain Inventory-short form [ Time Frame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks) ]
    The Brief Pain Inventory-short form (BPI-sf) questionnaire includes assessment of pain location and multiple aspects of severity of pain, numbness, tingling, and stiffness, including worst, least, average pain, and present, as well as the interference with daily activities. The Brief Pain Inventory-short form (BPI-sf) has a total score ranging from 0 to 10 with higher scores indicating more pain.

  2. Change in Physical Function as assessed by the Western Ontario and McMaster Osteoarthritis Index [ Time Frame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks) ]

    The Western Ontario and McMaster Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales:

    • Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing
    • Stiffness (2 items): after first waking and later in the day
    • Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.

    The WOMAC score range from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.


  3. Change in Physical disability as assessed by the QuickDASH [ Time Frame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks) ]
    QuickDASH outcome measure is used. At least 10 of the 11 items must be completed for a score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a score out of five. The value is then transformed to score out of 100. The score range will be 0 to 100. Higher score indicating greater disability.

  4. Change in Physical Strength as assessed by Handgrip [ Time Frame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks) ]
    Handgrip strength is a simple and commonly used test of a person's general strength level. There is a simple norm table which is categorized with age is used to measure the strength.


Secondary Outcome Measures :
  1. Change in medication use adherence as assessed by the Ecological Momentary Assessment [ Time Frame: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks) ]
    Analgesic use and Aromatase Inhibitor (AI) adherence will be included in the Ecological Momentary Assessment (EMA) diary during intervention and medications will be checked at study visits at follow-ups.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with a history of Breast Cancer (non-metastatic) before entering into postmenopausal age
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697200


Contacts
Contact: Chao H Yeh, PhD 4105021084 cyeh13@jhu.edu
Contact: Asha Krishna, MHA 4106146023

Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Chao H Yeh, PhD Johns Hopkins School of Nursing

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03697200     History of Changes
Other Study ID Numbers: IRB00189571
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Breast Cancer Survivors
Aromatase Inhibitor
Ecological Momentary Assessment
Musculoskeletal Symptoms

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs