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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

NCT07215364 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-10-10

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Spanish Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Study Director · Hospital Universitario Clínico San Cecilio, Granada, Spain

  • Study Director · Hospital Quirón Sagrado Corazón-Sevilla, Sevilla, Spain

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-03-31
Completion
2029-03-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215364 on ClinicalTrials.gov