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Impact of Exercise on Quality of Life of EBC Patients on Treatment With Adjuvant AI With or Without CDK4/6 Inhibitors
Sponsor: Spanish Breast Cancer Research Group
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.
Official title: Impact of EXercise on Quality of Life of Early Breast Cancer Patients on Treatment With Adjuvant Aromatase Inhibitors With or Without CDK4/6 Inhibitors. "The EXAI Study"
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2026-03
Completion Date
2029-03
Last Updated
2025-10-10
Healthy Volunteers
No
Conditions
Interventions
Training program
Training program consist on physical activity sessions (combined resistance plus aerobic exercises) that will be performed 3 times per week every-other-day.
Locations (5)
Institut Català d'Oncología (ICO) L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Clínico San Cecilio
Granada, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Quirón Sagrado Corazón de Sevilla
Seville, Spain