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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Postmenopausal
• Intervention / Treatment: Other: Acupressure; Other: Acupressure

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cancer AnswerLine; Phone Number: 1-800-865-1125; Email: CancerAnswerLine@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Comprehensive Cancer Center
      • Principal Investigator: Norah L Henry, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 surgery (mastectomy or lumpectomy/partial mastectomy) for treatment of breast cancer at least 3 months 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Acupressure Arm 1; 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; 9 acupoints will be stimulated for 3 minutes per point; Other: Acupressure; 9 areas will be stimulated for 3 minutes per point
Other: Acupressure Arm 2; 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; 9 acupoints will be stimulated for 3 minutes per point; Other: Acupressure; 9 areas will be stimulated for 3 minutes per point

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	12 weeks after intervention is started
safety of the intervention through reported adverse events	collected using CTCAE version 5.0	12 weeks after intervention is started

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: Breast Cancer Research Foundation
• Investigators: Principal Investigator: Norah Henry, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: joint pain; aromatase inhibitor; acupressure; arthralgia; AIMSS
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: UMCC 2023.084; HUM00241228 (Other Identifier: University of Michigan); BCRF-23-206 (Other Grant/Funding Number: Breast Cancer Research Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: participant demographics and patient-reported outcomes data will be available to researchers upon reasonable request
• IPD Sharing Time Frame: researchers can request data once the primary analysis has been published
• IPD Sharing Access Criteria: deidentified data will be available to researchers upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No