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Completed

NCT Number: NCT06228768

Acupressure for Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Patients With Breast Cancer

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.

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Key information

Conditions

Postmenopausal Arthralgia Breast Cancer Breast Diseases Breast Neoplasms Joint Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Acupressure

Other

9 acupoints will be stimulated for 3 minutes per point

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of patients with at least a 2 point reduction in pain (worst)

    Time frame: baseline and 12 weeks after intervention is started

    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.

  2. Proportion of patients with at least a 2 point reduction in pain (average)

    Time frame: baseline and 12 weeks after intervention is started

    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.

  3. Difference from baseline for pain interference

    Time frame: baseline, 6 weeks and 12 weeks after intervention is started

    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.

  4. Change in reported sleep disturbance

    Time frame: baseline, 6 weeks and 12 weeks after intervention is started

    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.

  5. Change in reported fatigue

    Time frame: baseline, 6 weeks and 12 weeks after intervention is started

    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.

  6. Change in reported physical function

    Time frame: baseline, 6 weeks and 12 weeks after intervention is started

    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.

  7. Change in anxiety

    Time frame: baseline, 6 weeks and 12 weeks after intervention is started

    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.

  8. Change in depression

    Time frame: baseline, 6 weeks and 12 weeks after intervention is started

    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.

  9. Change in cognitive function

    Time frame: baseline, 6 weeks and 12 weeks after intervention is started

    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.

  10. Adherence to trial intervention (number of days completed)

    Time frame: 12 weeks after intervention is started

    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.

  11. Adherence to trial intervention (number of minutes completed)

    Time frame: 12 weeks after intervention is started

    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.

  12. safety of the intervention through reported adverse events

    Time frame: 12 weeks after intervention is started

    collected using CTCAE version 5.0

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • Breast Cancer Research Foundation

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2024
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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