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RECRUITING

NCT07893327

Evaluation of the Effect of Regular Physical Exercise in Breast Cancer.

Sponsor: Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares

View on ClinicalTrials.gov

Summary

This study, titled "Evaluation of the effect of regular physical exercise in women with breast cancer on adjuvant hormone therapy," is a research project designed to see how guided exercise can help women recovering from breast cancer. Here is a simple summary of the study: Who is it for? The study includes 150 women who have finished their primary treatments (like surgery or chemotherapy) and are in the early stages of hormone therapy. The Goal: Researchers want to understand how regular exercise improves quality of life, physical fitness, and nutrition. They are also studying how exercise affects the immune system and the gut microbiota (the healthy bacteria in your body). The Exercise Program: Participants take part in a 16-week supervised program. It consists of two sessions per week: one in a gym and one in a swimming pool. These sessions are led by experts and are specifically adapted to each patient's physical condition and needs. Using Technology: To help with the study, participants use a mobile app (IALIBIRD) and a wearable activity tracker (like a bracelet). These tools monitor daily steps, sleep quality, and heart rate, and allow patients to report how they feel. Medical Check-ups: Throughout the study, patients have regular visits to the hospital for blood tests and to provide saliva and stool samples for biological analysis. They also have body scans (DXA) to measure bone health, muscle mass, and body fat. Why is this important? While hormone therapy is a vital treatment, it can last for 5 to 10 years and cause side effects like extreme tiredness, joint pain, and anxiety. This study aims to prove that regular exercise is a safe and effective way to reduce these symptoms and help women feel better during their recovery.

Official title: Evaluation of the Effect of Regular Physical Exercise in Women With Breast Cancer Undergoing Adjuvant Hormonal Therapy.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-01-17

Completion Date

2028-12

Last Updated

2026-10-23

Healthy Volunteers

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Interventions

OTHER

Supervised exercise program

6-week supervised exercise program for women with Stage I-III breast cancer receiving hormone therapy. Participants perform two weekly sessions (one gym, one pool) at the Dehesa Boyal Sports Center, led by specialists. The intervention progresses through four monthly phases: adaptation, base building, moderate progression, and consolidation. Intensity is tailored using the Borg Scale and heart rate monitors. A central component is the IALIBIRD-CM digital platform, where patients use an app and wearables to track activity, sleep, and symptoms.

Inclusion Criteria To participate in the study, subjects must meet all of the following requirements: Age and Diagnosis: Women over 18 years old diagnosed with Stage I, II, or III invasive breast carcinoma. Treatment Status: Must have completed primary oncological treatment (surgery, chemotherapy, and/or radiotherapy) and be within the first three months of starting adjuvant hormone therapy (tamoxifen or aromatase inhibitors). Physical Condition: A good general health status, defined as an ECOG performance status of 0-2, and the functional ability to perform supervised moderate physical exercise. Technical Requirements: Access to the internet and the ability to use the mobile application required for study evaluations. Consent: Voluntary agreement to participate, confirmed by a signed written informed consent form. Exclusion Criteria Patients will be excluded from the study if they meet any of the following conditions: Prior Exercise Habits: Having performed regular physical exercise (one hour or more per week) during the last six months. Limiting Symptoms: Presence of symptoms such as fever, chest pain, dizziness, blurred vision, or vomiting that would limit exercise. Clinical Parameters: Analytical lab results showing hemoglobin below 10 g/dL or a platelet count below 50,000. Medical Pathologies: Uncontrolled arrhythmias, heart failure, recent head trauma (within the last month), untreated osteoporosis, COPD, or cognitive impairment, among other contraindicating conditions. Oncological Status: Distant metastases or an active oncological disease other than breast cancer. Medications and Supplements: Currently taking or having taken antibiotics or probiotic supplements within the last 1.5 months. Other Factors: Pregnancy, breastfeeding, travel difficulties, or any inability to comply with the required technological follow-up. The selection process is prospective, aiming to recruit a total of 150 patients over three phases (50 patients per year). Participants who meet all criteria but do not wish to follow the exercise program may be assigned to the control group.

Locations (1)

Infanta Sofía University Hospital

San Sebastián de los Reyes, Madrid, Spain