Tai Chi for Reducing Aromatase Inhibitor-Induced Arthralgia
Recruiting · NCT07737951 · Interventional (participants receive a specific treatment) · Lead sponsor: Thomas Jefferson University
View the official record on ClinicalTrials.gov →Interventions studied
Health EducationTai Chi
What this trial is about
The objective of the pilot RCT is to evaluate the feasibility and acceptability of a Tai Chi intervention "TaiChi4Joint" vs. an HE AC group for relieving AIIA in women with hormone receptor positive stage I-III BCa. The investigators will pilot test our data collection for mechanism measures via three innovatively integrated biobehavioral pathways.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:
- Age ≥18 years
- Diagnosis of stage I-III hormone receptor-positive breast cancer
- Postmenopausal
- Currently receiving an aromatase inhibitor (anastrozole, letrozole, or exemestane) or within 5 years of initiation
- Report joint pain that started or worsened after initiation of AI therapy
- Report worst pain in the past week ≥3 on the BPI (0-10 scale)
- Able to complete study procedures in English
- Willing to be randomized to an intervention or attention control group and adhere to study procedures
Exclusion criteria
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Undergoing active cancer treatment (excluding endocrine therapy)
- Uncontrolled cardiac or pulmonary disease that would limit safe participation
- Currently engaged in regular structured moderate- or vigorous-intensity exercise (e.g., brisk walking, jogging/running, cycling, swimming, aerobic classes, or resistance training) totaling ≥150 minutes per week over the past 3 months
- Currently participating in Tai Chi, yoga, Pilates, or other structured mind-body practice ≥2 times per week over the past 3 months
- Joint pain due to inflammatory arthritic conditions
- Recent surgery or joint injection within the past 4-6 weeks
- Initiation or dose change of corticosteroids or opioids within the past 4 weeks
- Planned discontinuation of AI therapy within the next 6 months
- This study is limited to women with breast cancer, as \<1% of cases occur in men and data on AIIA in male patients are limited
Where it is running
1 location listed across 1 US state.
- Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Pennsylvania, United States