Clinical trial NCT06228768: Acupressure for Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Patients With Breast Cancer
Official title: Acupressure for Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postmenopausal
Breast Cancer
Keywords: acupressure
arthralgia
aromatase inhibitor
joint pain
AIMSS
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2024-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to two different sets of acupressure points
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in joint pain
timeFrame: baseline and 12 weeks after intervention is started
Secondary outcomes:
measure: Proportion of patients with at least a 2 point reduction in pain (worst)
timeFrame: baseline and 12 weeks after intervention is started
measure: Proportion of patients with at least a 2 point reduction in pain (average)
timeFrame: baseline and 12 weeks after intervention is started
measure: Difference from baseline for pain interference
timeFrame: baseline, 6 weeks and 12 weeks after intervention is started
measure: Change in reported sleep disturbance
timeFrame: baseline, 6 weeks and 12 weeks after intervention is started
measure: Change in reported fatigue
timeFrame: baseline, 6 weeks and 12 weeks after intervention is started
measure: Change in reported physical function
timeFrame: baseline, 6 weeks and 12 weeks after intervention is started
measure: Change in anxiety
timeFrame: baseline, 6 weeks and 12 weeks after intervention is started
measure: Change in depression
timeFrame: baseline, 6 weeks and 12 weeks after intervention is started
measure: Change in cognitive function
timeFrame: baseline, 6 weeks and 12 weeks after intervention is started
measure: Adherence to trial intervention (number of days completed)
timeFrame: 12 weeks after intervention is started
measure: Adherence to trial intervention (number of minutes completed)
timeFrame: 12 weeks after intervention is started
measure: safety of the intervention through reported adverse events
timeFrame: 12 weeks after intervention is started
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Norah Henry
role: PRINCIPAL_INVESTIGATOR
References: