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NOT YET RECRUITING
NCT07215364
NA

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

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

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