Overview
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.
Description
- Study Overview and Justification This project is an experimental clinical study promoted by a multidisciplinary consortium including IMDEA Nutrition, Hospital Universitario Infanta Sofía (HUIS), CSIC, and the Polytechnic University of Madrid (UPM).
Breast cancer is the most frequent tumor in women, and approximately 70% of cases are hormone-receptor positive, requiring adjuvant hormone therapy for 5 to 10 years. While effective, this treatment often causes side effects like fatigue (asthenia), joint pain, anxiety, and bone density loss, which significantly diminish patients' quality of life. Scientific evidence suggests that exercise can reduce cancer risk, improve survival, and mitigate these side effects by modulating molecular pathways (like IGF-1), stimulating the immune system (NK cells), and improving the gut microbiota. 2. Objectives and Primary Variables The general objective is to evaluate how a regular exercise program impacts the quality of life, physical condition, body composition, nutritional status, and biological markers of these patients.
Specific objectives include:
Designing a digital health framework for personalized care. Identifying microbiota profiles and genetic polymorphisms (SNPs) that correlate with exercise response.
Analyzing epigenetic marks (DNA methylation) and metabolomic profiles. Evaluating the usability and adherence to the IALIBIRD-CM digital platform. The primary variable is the variation in general health status and quality of life measured through validated questionnaires and biological biomarkers. 3. Study Population and Selection The study will recruit 150 participants across three yearly phases (50 patients per phase).
Inclusion Criteria: Women over 18 with Stage I, II, or III breast cancer; finished primary treatment (surgery, chemo, or radiotherapy); within their first 3 months of hormone therapy (Tamoxifen or Aromatase inhibitors); and an ECOG status of 0-2.
Exclusion Criteria: Patients already exercising regularly (\>1 hour/week in the last 6 months); presence of metastases; or current use of antibiotics/probiotics (within 1.5 months). 4. The Exercise Intervention The intervention consists of a 16-week (4-month) supervised program. Participants attend two sessions per week at the Dehesa Boyal Sports Center: one in a gym/multipurpose room and one in a pool.
The program is divided into four blocks:
Month 1 (Adaptation): Focus on technical familiarization, mobility, and tolerance with low intensity.
Month 2 (Base Construction): Increasing volume and introducing light-to-moderate loads.
Month 3 (Moderate Progression): Improving functional strength and cardiorespiratory capacity.
Month 4 (Consolidation): Focused on functional circuits and autonomy. Intensity is individually monitored using the Borg Scale of Perceived Exertion (targeting a score of 5-6 by Month 4) and heart rate trackers. 5. Multidimensional Evaluation and Biomarkers
Patients undergo five hospital visits (V0 to V4) for comprehensive monitoring:
Anthropometry: Body composition is measured via DXA scans (bone density, muscle mass, and visceral fat) and bioimpedance.
Omics \& Lab Tests: Blood, stool, saliva, and 24-hour urine samples are analyzed for:
Gut Microbiota: 16S rRNA sequencing to study bacterial diversity. Genetics/Epigenetics: Analysis of SNPs related to metabolism and inflammation, and genome-wide DNA methylation.
Immune Markers: Flow cytometry to study lymphocyte populations (NK, CD8+, etc.) and immunosenescence markers.
Questionnaires: Validated tools assess quality of life (EORTC QLQ-C30/BR-23), depression (PHQ-9), anxiety (STAI), sleep (Pittsburgh), and cognitive status ("chemobrain"). 6. Digital Health and Artificial Intelligence A cornerstone of the study is the IALIBIRD-CM platform, which uses a mobile app and wearables.
Passive Variables: Real-time data on steps, sleep efficiency, and heart rate variability.
Active Variables: Ecological Momentary Assessment (EMA) allows patients to report mood, fatigue, and symptoms directly through the app.
AI Integration: The study explores machine learning to identify patient profiles and predict treatment responses, eventually moving toward a federated data architecture to protect privacy in clinical settings. 7. Ethics and Data Management The study adheres to the Declaration of Helsinki and strict EU/Spanish data protection regulations (RGPD). Participants provide written informed consent and may withdraw at any time. Data is handled through a pseudo-anonymized system using platforms like REDCap to ensure participant privacy and data integrity.
Eligibility
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.
