PostmenopausalNCT06228768
Acupressure for Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Patients With Breast Cancer
A study testing Acupressure in people with Postmenopausal and Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This is a randomized, double-blinded trial of self-acupressure to examine the effect of treatment on aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS) in postmenopausal women with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postmenopausal, Breast Cancer
- What is being tested?
- Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2024to 16 Nov 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male subject aged ≥ 18 years
- Taking the currently prescribed aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant or palliative treatment of breast cancer or for chemoprevention for at least 3 weeks and no more than 2 years at the time of enrollment.
- Planning to take the same AI therapy for at least 12 weeks.
- New or worsening joint pain and/or myalgias since starting the AI therapy, with worst pain score of at least 4 out of 10 on the BPI over the 7 days prior to enrollment.
- Completion of radiation therapy, if given, for treatment of breast cancer.
- Completion of chemotherapy, if given. Concurrent use of LHRHa therapy, anti-HER2 therapy, bisphosphonate therapy, PARP inhibitor therapy, and CDK4/6 inhibitor therapy is permitted.
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- Patients receiving treatment with NSAIDs, acetaminophen, opioids, duloxetine, cannabinoids, gabapentin, and/or pregabalin must have been taking a stable dose for at least 30 days prior to enrollment if they plan to continue the drug during study participation. If they do not plan to take the medication during study participation, they should stop the medication at least 7 days before initiation of study treatment.
- Able to self-complete questionnaires in English.
- Able to access WiFi/internet and willing to use an email account or download and use the MyDataHelps app.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Use of acupuncture or acupressure in the past year, or planned use of acupuncture during study participation.
- Use of systemic or transdermal estrogen during study participation.
- Planned surgery during the 12-week study period.
- Concurrent medical or arthritis disease such as painful bone metastases or active rheumatoid arthritis or inflammatory arthritis that could confound or interfere with evaluation of pain or efficacy. Patients with osteoarthritis and asymptomatic bone metastases are eligible.
- Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
This is a randomized, double-blinded trial of self-acupressure to examine the effect of treatment on aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS) in postmenopausal women with breast cancer. Acupressure is similar to acupuncture, but uses pressure rather than needles to stimulate specific points on the body. Acupressure involves applying mild to moderate physical pressure using your fingers, or an assistive device, to these points to try to bring about a physiological change in your body, in this case relief from joint pain and stiffness. The investigators will also examine effects of acupressure on other symptoms that commonly develop in AI-treated patients. In addition, changes in stool microbiome with acupressure treatment will be examined in an exploratory way to obtain preliminary information about the effect of acupressure on the gut microbiome in this condition.
- Conditions
- Postmenopausal, Breast Cancer
- Being tested
- Acupressure
- Keywords
- acupressure, arthralgia, aromatase inhibitor, joint pain, AIMSS
- Medical subject headings
- Breast Neoplasms, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
9 acupoints will be stimulated for 3 minutes per point
AcupressureOther
9 areas will be stimulated for 3 minutes per point
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Arm 1 | Other | There are 5 acupoints with 4 of the acupoints performed on both the left and right sides of the body. Each of the 9 acupoints will be stimulated for 3 minutes per point with the AcuWand giving a total treatment time of 27 minutes daily. The relaxation acupoints are unlisted in order to maintain blinding. Receives: Other: Acupressure |
| Acupressure Arm 2 | Other | There are 5 acupoints with 4 of the acupoints performed on both the left and right sides of the body. Each of the 9 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 27 minutes daily. The acupoints are unlisted in order to maintain blinding. Receives: Other: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in joint pain
Range 0-10 after 12 weeks of intervention. Brief Pain Inventory (BPI) questionnaire will be used for this assessment. Comparison of baseline and 12 week assessment.
Measured: baseline and 12 weeks after intervention is started
Secondary outcomes (12)
Proportion of patients with at least a 2 point reduction in pain (worst)
The proportion of patients who have at least a 2-point reduction in worst pain from baseline to 12 weeks will be reported with the corresponding exact binomial confidence intervals in each treatment group. The proportions will be compared using a chi-square test for each outcome. Differences from baseline at each time point for worst pain will be summarized via mean and standard deviation. Linear models using generalized estimating equations will assess the change in worst pain over time between groups similar to the primary endpoint. Brief Pain Inventory (BPI) questionnaire will be used for this assessment.
Measured: baseline and 12 weeks after intervention is started
Proportion of patients with at least a 2 point reduction in pain (average)
The proportion of patients who have at least a 2-point reduction in average pain from baseline to 12 weeks will be reported with the corresponding exact binomial confidence intervals in each treatment group. The proportions will be compared using a chi-square test for each outcome. Differences from baseline at each time point for worst pain will be summarized via mean and standard deviation. Linear models using generalized estimating equations will assess the change in average pain over time between groups similar to the primary endpoint. Brief Pain Inventory (BPI) questionnaire will be used for this assessment.
Measured: baseline and 12 weeks after intervention is started
Difference from baseline for pain interference
Brief Pain Inventory (BPI) questionnaire will be used for this assessment. Differences from baseline at each time point for pain interference (range 0-10) will be summarized via mean and standard deviation. Linear models using generalized estimating equations will assess the change in pain interference over time between groups similar to the primary endpoint.
Measured: baseline, 6 weeks and 12 weeks after intervention is started
Change in reported sleep disturbance
PROMIS Profile 29- sleep disturbance [range 32-73.3]. Patient reported outcomes will be analyzed using linear models and generalized estimating equations with robust variance similar to the primary outcome.
Measured: baseline, 6 weeks and 12 weeks after intervention is started
Change in reported fatigue
PROMIS Profile 29-fatigue [range 33.7-75.8]. Patient reported outcomes will be analyzed using linear models and generalized estimating equations with robust variance similar to the primary outcome.
Measured: baseline, 6 weeks and 12 weeks after intervention is started
Change in reported physical function
PROMIS Profile 29 -physical function [range 22.5-57]. Patient reported outcomes will be analyzed using linear models and generalized estimating equations with robust variance similar to the primary outcome.
Measured: baseline, 6 weeks and 12 weeks after intervention is started
Change in anxiety
PROMIS Profile 29-anxiety [range 40.3-81.6].Patient reported outcomes will be analyzed using linear models and generalized estimating equations with robust variance similar to the primary outcome.
Measured: baseline, 6 weeks and 12 weeks after intervention is started
Change in depression
PROMIS Profile 29-depression [range 41-79.4]. Patient reported outcomes will be analyzed using linear models and generalized estimating equations with robust variance similar to the primary outcome.
Measured: baseline, 6 weeks and 12 weeks after intervention is started
Change in cognitive function
PROMIS Profile 29-cognitive function [range 29.4-61.2]. Patient reported outcomes will be analyzed using linear models and generalized estimating equations with robust variance similar to the primary outcome.
Measured: baseline, 6 weeks and 12 weeks after intervention is started
Adherence to trial intervention (number of days completed)
Adherence will be calculated based on number of days acupressure is performed The proportion of participants who are fully adherent will be compared between groups using a chi-square test.
Measured: 12 weeks after intervention is started
Adherence to trial intervention (number of minutes completed)
Adherence will be calculated based on number of minutes of acupressure performed each day. The proportion of participants who are fully adherent will be compared between groups using a chi-square test.
Measured: 12 weeks after intervention is started
safety of the intervention through reported adverse events
collected using CTCAE version 5.0
Measured: 12 weeks after intervention is started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start6 Mar 2024
- Primary completion16 Nov 2025
- Study completion16 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PostmenopausalStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to two different sets of acupressure points
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Norah Henry, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228768
- Sponsor's protocol ID
- UMCC 2023.084
- Other IDs
- HUM00241228, BCRF-23-206
- Status last verified
- Dec 2025
- First submitted
- 16 Jan 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: participant demographics and patient-reported outcomes data will be available to researchers upon reasonable request
Publications
Henry NL, Kidwell KM, Kozar S, Snyder S, Zick SM. Self-acupressure for patients with breast cancer experiencing aromatase inhibitor-associated musculoskeletal symptoms: Protocol for the AcuAIM randomized pilot trial. PLoS One. 2025 Jan 22;20(1):e0311044. doi: 10.1371/journal.pone.0311044. eCollection 2025.
PubMed 39841658
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupressure for Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT06228768
- Acronym / sponsor ID
- UMCC 2023.084
- Conditions
- Postmenopausal, Breast Cancer
- Keywords
- acupressure, arthralgia, aromatase inhibitor, joint pain, AIMSS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 16 Nov 2025 (actual)
- Study completion
- 16 Nov 2025 (actual)
- First posted
- 29 Jan 2024 (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.
This is a randomized, double-blinded trial of self-acupressure to examine the effect of treatment on aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS) in postmenopausal women with breast cancer. Acupressure is similar to acupuncture, but uses pressure rather than needles to stimulate specific points on the body. Acupressure involves applying mild to moderate physical pressure using your fingers, or an assistive device, to these points to try to bring about a physiological change in your body, in this case relief from joint pain and stiffness. The investigators will also examine effects of acupressure on other symptoms that commonly develop in AI-treated patients. In addition, changes in stool microbiome with acupressure treatment will be examined in an exploratory way to obtain preliminary information about the effect of acupressure on the gut microbiome in this condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to two different sets of acupressure points
| Arm | Type | Receives |
|---|---|---|
| Acupressure Arm 1 | Other | Other: AcupressureThere are 5 acupoints with 4 of the acupoints performed on both the left and right sides of the body. Each of the 9 acupoints will be stimulated for 3 minutes per point with the AcuWand giving a total treatment time of 27 minutes daily. The relaxation acupoints are unlisted in order to maintain blinding. |
| Acupressure Arm 2 | Other | Other: AcupressureThere are 5 acupoints with 4 of the acupoints performed on both the left and right sides of the body. Each of the 9 acupoints will be stimulated for 3 minutes per point giving a total treatment time of 27 minutes daily. The acupoints are unlisted in order to maintain blinding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female or male subject aged ≥ 18 years
- Taking the currently prescribed aromatase inhibitor therapy (anastrozole, exemestane, or letrozole) for adjuvant or palliative treatment of breast cancer or for chemoprevention for at least 3 weeks and no more than 2 years at the time of enrollment.
- Planning to take the same AI therapy for at least 12 weeks.
- New or worsening joint pain and/or myalgias since starting the AI therapy, with worst pain score of at least 4 out of 10 on the BPI over the 7 days prior to enrollment.
- Completion of radiation therapy, if given, for treatment of breast cancer.
Key exclusion criteria (5 listed)
- Use of acupuncture or acupressure in the past year, or planned use of acupuncture during study participation.
- Use of systemic or transdermal estrogen during study participation.
- Planned surgery during the 12-week study period.
- Concurrent medical or arthritis disease such as painful bone metastases or active rheumatoid arthritis or inflammatory arthritis that could confound or interfere with evaluation of pain or efficacy. Patients with osteoarthritis and asymptomatic bone metastases are eligible.
- Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
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 |
|---|---|---|
| Acupressure9 acupoints will be stimulated for 3 minutes per point | Other | Acupressure Arm 1 |
| Acupressure9 areas will be stimulated for 3 minutes per point | Other | Acupressure Arm 2 |
Primary outcome
Change in joint pain
Time frame: baseline and 12 weeks after intervention is started
Range 0-10 after 12 weeks of intervention. Brief Pain Inventory (BPI) questionnaire will be used for this assessment. Comparison of baseline and 12 week assessment.
12 secondary outcomes
Proportion of patients with at least a 2 point reduction in pain (worst)
Time frame: baseline and 12 weeks after intervention is started
Proportion of patients with at least a 2 point reduction in pain (average)
Time frame: baseline and 12 weeks after intervention is started
Difference from baseline for pain interference
Time frame: baseline, 6 weeks and 12 weeks after intervention is started
Change in reported sleep disturbance
Time frame: baseline, 6 weeks and 12 weeks after intervention is started
Change in reported fatigue
Time frame: baseline, 6 weeks and 12 weeks after intervention is started
Change in reported physical function
Time frame: baseline, 6 weeks and 12 weeks after intervention is started
Change in anxiety
Time frame: baseline, 6 weeks and 12 weeks after intervention is started
Change in depression
Time frame: baseline, 6 weeks and 12 weeks after intervention is started
Change in cognitive function
Time frame: baseline, 6 weeks and 12 weeks after intervention is started
Adherence to trial intervention (number of days completed)
Time frame: 12 weeks after intervention is started
Adherence to trial intervention (number of minutes completed)
Time frame: 12 weeks after intervention is started
safety of the intervention through reported adverse events
Time frame: 12 weeks after intervention is started
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 23 Dec 2025.
- Derived from this study: PubMed 39841658Henry NL, Kidwell KM, Kozar S, Snyder S, Zick SM. Self-acupressure for patients with breast cancer experiencing aromatase inhibitor-associated musculoskeletal symptoms: Protocol for the AcuAIM randomized pilot trial. PLoS One. 2025 Jan 22;20(1):e0311044. doi: 10.1371/journal.pone.0311044. eCollection 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. participant demographics and patient-reported outcomes data will be available to researchers upon reasonable request
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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.
Norah Henry principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Postmenopausal and Breast Cancer, run by University of Michigan Rogel Cancer Center 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 10 inclusion and 5 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 23 Dec 2025. 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. 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 joint pain (time frame: baseline and 12 weeks after intervention is started). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06228768, which also lists 1 linked publication.
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 23 Dec 2025.