Aromatase InhibitorNCT03697200
Auricular Point Acupressure to Self-Manage Chronic Pain or Aromatase Inhibitor Musculoskeletal Symptoms in Breast Cancer Survivors: Effectiveness and Scientific Underpinnings
A study testing APA in people with Aromatase Inhibitor and Musculoskeletal Symptoms, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Aromatase Inhibitor, Musculoskeletal Symptoms, Postmenopausal Breast Cancer Survivors
- What is being tested?
- APA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2018to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
About this study
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.
- Being tested
- APA, Sham APA control, Education control
- Keywords
- Breast Cancer Survivors, Aromatase Inhibitor, Ecological Momentary Assessment, Musculoskeletal Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APAOther
Light touch using vaccaria seeds on specific points of the ear
Sham APA controlOther
Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
Education controlOther
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
| Study group | Role | What they receive |
|---|---|---|
| Auricular Point Acupressure (APA) | Active comparator | 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) Receives: Other: APA |
| Sham APA control | Sham comparator | 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. Receives: Other: Sham APA control |
| Education Control | Other | 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. Receives: Other: Education control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity as assessed by the Brief Pain Inventory-short form
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.
Measured: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks)
Change in Physical Function as assessed by the Western Ontario and McMaster Osteoarthritis Index
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.
Measured: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks)
Change in Physical disability as assessed by the QuickDASH
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.
Measured: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks)
Change in Physical Strength as assessed by Handgrip
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.
Measured: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks)
Secondary outcomes (1)
Change in medication use adherence as assessed by the Ecological Momentary Assessment
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.
Measured: Baseline, pre- Intervention (4 weeks), post-intervention (8 weeks), one-month (12 weeks), 2-month (16 weeks), and 3-month (20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start11 Nov 2018
- Primary completion1 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aromatase InhibitorStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao H Yeh, PhD, Principal investigator, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697200
- Sponsor's protocol ID
- IRB00158622
- Status last verified
- Jul 2021
- First submitted
- 3 Oct 2018
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Point Acupressure to Self-Manage Chronic Pain or Aromatase Inhibitor Musculoskeletal Symptoms in Breast Cancer Survivors: Effectiveness and Scientific Underpinnings
- ClinicalTrials.gov ID
- NCT03697200
- Acronym / sponsor ID
- IRB00158622
- Keywords
- Breast Cancer Survivors, Aromatase Inhibitor, Ecological Momentary Assessment, Musculoskeletal Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auricular Point Acupressure (APA) | Active comparator | Other: APAPatients 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) |
| Sham APA control | Sham comparator | Other: Sham APA controlThe 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. |
| Education Control | Other | Other: Education controlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APALight touch using vaccaria seeds on specific points of the ear | Other | Auricular Point Acupressure (APA) |
| Sham APA controlLight touch using vaccaria seeds on different points of the ear (compared to the APA group). | Other | Sham APA control |
| Education controlParticipants 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 | Other | Education Control |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao H Yeh, PhD principal investigator
Johns Hopkins School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APA in people with Aromatase Inhibitor and Musculoskeletal Symptoms, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.