Clinical Trial

Impact of Exercise on Quality of Life of EBC Patients on Treatment With Adjuvant AI With or Without CDK4/6 Inhibitors

Study acronym: EX-AI
Recruiting
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Summary
This is a national clinical trial (Spain), conducted in approximately 5 sites, where patients who agree to participate will be included in one of two exercise program groups: the experimental group (a combined resistance and aerobic exercise program) and the control group. The study will begin with a pilot phase involving approximately 74 patients. Approximately 37 patients in the experimental group will follow a 6-month training program consisting of exercise sessions three alternate days per week (combining resistance and aerobic exercise). Approximately 37 patients in the control group will receive standard medical care. These patients will be provided with international exercise guidelines for cancer patients. Patients will continue with their assigned physical activity intervention until the maximum number of months for the intervention, unacceptable toxicity, discontinuation of hormone therapy, or withdrawal of consent-whichever occurs first.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-30
Trial Details
NCT Number NCT07215364
Lead Sponsor Spanish Breast Cancer Research Group
Conditions Early-stage Breast Cancer
Enrollment 74 participants
Start Date 2026-07-02
Primary Completion 2028-03 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-29