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