Tailored exercise to prevent aromatase inhibitor–related joint and muscle symptoms
Effectiveness of Tailored Home-based Exercise on Aromatase Inhibitor-associated Musculoskeletal Symptoms in Breast Cancer Patients Receiving Adjuvant Aromatase Inhibitor: A Randomized, Controlled Trial
This will test whether a personalized exercise program can prevent joint and muscle pain in people with early breast cancer who are starting aromatase inhibitor therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT07448558 on ClinicalTrials.gov |
What this trial studies
Participants will be randomized to a tailored exercise program or to routine practice to see if targeted exercise prevents aromatase inhibitor–associated musculoskeletal symptoms. The tailored program is individualized based on each participant's baseline activity and symptoms and delivered at the Faculty of Medicine Siriraj Hospital, Mahidol University. Key eligibility includes patients with early breast cancer who began adjuvant aromatase inhibitor therapy within the past 4 weeks; exclusions include chronic arthritis, recent major cardiac events, and people already exercising more than 150 minutes per week. Outcomes will compare the incidence and severity of musculoskeletal symptoms between the tailored exercise and usual-care groups.
Who should consider this trial
Good fit: People with early-stage breast cancer who have started adjuvant aromatase inhibitor therapy within the last 4 weeks and who do not already exercise more than 150 minutes per week.
Not a fit: Patients with chronic arthritis, a recent heart failure or acute coronary syndrome, or those already exercising regularly over 150 minutes per week are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, the program could reduce joint and muscle pain and help more patients continue aromatase inhibitor therapy.
How similar studies have performed: Previous randomized and observational studies of exercise for aromatase inhibitor–related musculoskeletal symptoms have reported mixed but generally promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * breast cancer patients with starting adjuvant aromatase inhibitor within 4 weeks * able to read and write Exclusion Criteria: * chronic arthritis * history of heart failure or acute coronary syndrome within 6 months * individuals who exercises regularly more than 150 minutes/week
Where this trial is running
Bangkok
- Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: Suthinee Ithimakin, M.D
- Email: aesi105@yahoo.co.th
- Phone: +66898127440
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.