NCT07025213 Metabolic Effect of Exercise and Diet in Endometrial Cancer Patients Eligible for Staging Surgery.

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This trial targets 80 participants in total. It began in 2025-04-02 with a primary completion date of 2027-06-30.

Brief Summary

Background: Endometrial cancer is one of the diseases linked to obesity in women. In Mexico, about 7.6 women out of every 100,000 are diagnosed with this type of cancer, and nearly three-quarters of these women have obesity. Many women with endometrial cancer also have a condition called sarcopenic obesity, where muscle loss happens but might not be easy to identify. Researchers believe that certain molecules in the blood could help identify the health of muscles. Exercise helps muscles stay strong and healthy by affecting these molecules. For women with cancer, staying active can help maintain muscle mass, which is important for better recovery and health outcomes. This project focuses on an exercise program for women with locally advanced endometrial cancer who will be treated surgically at the National Cancer Institute of Mexico (INCan). What We Think Will Happen: Women with endometrial cancer who participate in a program combining physical activity and healthy eating will gain more muscle strength and function compared to those who don't exercise. We expect these changes to be connected to healthier levels of certain molecules in the blood, showing less muscle breakdown and less inflammation. We also believe these women will have better control of blood sugar and fats. Our Main Goal: To find out how physical activity and diet affect muscle health and metabolism in women with endometrial cancer, and to compare these changes to women who don't participate in the exercise program. How We Will Do It: We will measure molecules related to muscle health in the blood. We will also assess muscle size, strength, and how well the muscles work. Then, we will look for connections between these muscle changes and the blood molecules. We want to see if improvements in muscle are linked to better recovery from surgery and better health outcomes. If so, these blood molecules might help doctors monitor muscle health. We hope that the exercise program will help women recover better and improve their quality of life. How We Will Analyze the Data: We will describe the data we collect and compare the group that exercises to the group that doesn't. We will use statistics to see if the differences are meaningful. We will also analyze the relationship between muscle health and blood markers. Advanced methods will help us identify which molecules and measurements best explain the changes seen. The results will be carefully reviewed using specialized software. What We Hope to Find: We aim to show that blood tests can help identify muscle health and how it improves with exercise. This could lead to earlier detection of muscle loss and better management through exercise programs. Ultimately, this work hopes to improve the health and well-being of women facing endometrial cancer.

Eligibility Criteria

Inclusion Criteria: 1. -Ability to understand the nature of the study and provide written informed consent. 2. -Women aged over 18 and under 65 years. 3. -Availability to attend exercise sessions. 4. -Willingness and ability to comply with scheduled visits, the proposed nutritional algorithm, treatment plan, and laboratory tests. 5. -Histologically confirmed diagnosis of endometrioid-type endometrial cancer by biopsy. 6. -Normal electrocardiogram (ECG) result. 7. -No prior oncological treatment. 8. -Body mass index (BMI) greater than 20 kg/m². 9. -Availability of a computed tomography (CT) scan. 10. -Candidates for staging surgery. Exclusion Criteria: 1. -Patients with advanced clinical stage or stage IVB disease (according to FIGO 2018 criteria). 2. -Patients with a prior or concurrent malignancy, except non-melanoma skin cancer. 3. -Patients with uncontrolled systemic arterial hypertension. 4. -Patients with renal dysfunction (eGFR ≤ 60 mL/min/1.73 m²). 5. -Patients with uncontrolled psychiatric disorders, including claustrophobia. 6. -Patients with concurrent infections. 7. -Patients with autoimmune disease. 8. -Patients with neuromuscular disease. 9. -Contraindications to physical exercise. 10. -Vulnerable situations (e.g., homelessness preventing adherence to diet, or incarceration).

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