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

Condition(s) studied

Investigational drug(s) / intervention(s)

Diet and exercise.: The intervention group will receive recommendations to follow an anti-inflammatory diet. In addition, they will be instructed to increase their level of physical activity and will be asked to attend the institute to carry out a supervised exercise routine.

Diet.: The comparison group will be instructed to follow the anti-inflammatory diet intervention only.

Study 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

Primary outcome measure(s)

• Changes in serum tyrosine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum histidine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum lysine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum phenylalanine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum glutamic acid concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum methionine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum aspartic acid concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum proline concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum serine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum threonine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum isoleucine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum valine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum leucine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum glycine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum cystine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum alanine concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum IL-6 concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum IL-10 concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum TGF-betha concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum TNF-alpha concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum creatine kinase concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum irisin concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum decorin concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in serum musclin concentration after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks
• Changes in total blood cholesterol after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks.
• Changes in blood LDL cholesterol after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks.
• Changes in blood HDL cholesterol after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks.
• Changes in blood triglycerides after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks.
• Changes in blood glucose after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks.
• Changes in insulin after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks.
• Changes in glycosylated hemoglobin after the physical activity plus diet intervention, compared to patients receiving diet only. — From enrollment to the end of treatment at 4 weeks.
• Changes in muscle mass after the physical activity plus diet intervention, compared to patients receiving diet only. — 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. — 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. — From enrollment to the end of treatment at 4 weeks.

Trial sites (1)

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