Acupressure for joint pain relief in breast cancer patients on aromatase inhibitors
Acupressure for Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Patients With Breast Cancer
This study is testing whether self-applied acupressure can help relieve joint pain in postmenopausal women with breast cancer who are taking aromatase inhibitors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06228768 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of self-administered acupressure on musculoskeletal symptoms associated with aromatase inhibitor therapy in postmenopausal women with breast cancer. Participants will apply pressure to specific points on their bodies to alleviate joint pain and stiffness, with the study also exploring potential changes in the gut microbiome. The trial is randomized and double-blinded to ensure unbiased results, and it requires participants to have been on aromatase inhibitors for a specified duration. The study aims to provide insights into both symptom relief and broader physiological effects of acupressure.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women currently taking aromatase inhibitors and experiencing significant joint pain.
Not a fit: Patients who are not experiencing joint pain or who are not on aromatase inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological method to alleviate joint pain for breast cancer patients undergoing aromatase inhibitor therapy.
How similar studies have performed: Previous studies have shown promising results for acupressure in managing various types of pain, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Norah Henry — University of Michigan Rogel Cancer Center
- Study coordinator: Cancer AnswerLine
- Email: FAMMED-breast-cancer-trials@med.umich.edu
- Phone: 1-800-865-1125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.