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

NCT06228768 | Completed

• 3 other identifiers: UMCC 2023.084HUM00241228BCRF-23-206
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

acupressure; arthralgia; aromatase inhibitor; joint pain; AIMSS

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and 12 weeks after intervention is started

Secondary Outcomes (12)

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

  baseline and 12 weeks after intervention is started

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

  baseline and 12 weeks after intervention is started

• Difference from baseline for pain interference

  baseline, 6 weeks and 12 weeks after intervention is started

• Change in reported sleep disturbance

  baseline, 6 weeks and 12 weeks after intervention is started

• Change in reported fatigue

  baseline, 6 weeks and 12 weeks after intervention is started

Study Arms (2)

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.

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.

Other: Acupressure

Interventions

Acupressure OTHER

9 acupoints will be stimulated for 3 minutes per point

Acupressure Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Breast Cancer Research Foundation: collaborator
• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 39841658 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia

Interventions

Acupressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Norah Henry

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Both clinicians and participants will be blinded to study arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to two different sets of acupressure points

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 29, 2024
• Study Start: March 6, 2024
• Primary Completion: November 16, 2025
• Study Completion: November 16, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: researchers can request data once the primary analysis has been published
• Access Criteria: deidentified data will be available to researchers upon reasonable request

Locations

US (1)