Metabolic Effect of a Physical Activity and Dietary Intervention, and Its Association With Musculoskeletal Changes, in Endometrial Cancer Patients Eligible for Staging Surgery, Compared to Patients Not Receiving the Physical Activity Intervention. A Pilot Study.

National Institute of Cancerología1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2025年4月2日最近更新: 2025年6月17日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 80
试验地点: 1
主要终点: Changes in muscle mass after the physical activity plus diet intervention, compared to patients receiving diet only.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

What is Endometrial Cancer (EC)?

EC is a cancer that starts in the lining of the uterus.
The number of cases worldwide, including Mexico, has been rising steadily over the past decades.
Most cases are found early (stage I), and there are two main types:

Type I (most common): linked to hormones like estrogen, usually has a better outlook.

-Type II: less common and not related to estrogen.

What Increases the Risk of EC?

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Ability to understand the nature of the study and provide written informed consent.
•Women aged over 18 and under 65 years.
•Availability to attend exercise sessions.
•Willingness and ability to comply with scheduled visits, the proposed nutritional algorithm, treatment plan, and laboratory tests.
•Histologically confirmed diagnosis of endometrioid-type endometrial cancer by biopsy.
•Normal electrocardiogram (ECG) result.
•No prior oncological treatment.
•Body mass index (BMI) greater than 20 kg/m².
•Availability of a computed tomography (CT) scan.
•Candidates for staging surgery.

排除标准

•Patients with advanced clinical stage or stage IVB disease (according to FIGO 2018 criteria).
•Patients with a prior or concurrent malignancy, except non-melanoma skin cancer.
•Patients with uncontrolled systemic arterial hypertension.
•Patients with renal dysfunction (eGFR ≤ 60 mL/min/1.73 m²).
•Patients with uncontrolled psychiatric disorders, including claustrophobia.
•Patients with concurrent infections.
•Patients with autoimmune disease.
•Patients with neuromuscular disease.
•Contraindications to physical exercise.
•Vulnerable situations (e.g., homelessness preventing adherence to diet, or incarceration).

研究组 & 干预措施

Diet.

Active Comparator

This group will only receive recommendations to follow an anti-inflammatory diet.

干预措施: Diet. (Other)

Diet and exercise.

Experimental

The intervention group will receive both dietary and exercise interventions.

干预措施: Diet and exercise. (Other)

结局指标

主要结局

Changes in muscle mass after the physical activity plus diet intervention, compared to patients receiving diet only.

时间窗: From enrollment to the end of treatment at 4 weeks.

Changes in hand strength after the physical activity plus diet intervention, compared to patients receiving diet only.

时间窗: From enrollment to the end of treatment at 4 weeks.

Changes in physical function after the physical activity plus diet intervention, compared to patients receiving diet only.

时间窗: From enrollment to the end of treatment at 4 weeks.

Changes in serum tyrosine concentration after the physical activity plus diet intervention, compared to patients receiving diet only.