An interventional study of Diet and exercise. and Diet. in Endometrial Cancer, sponsored by National Institute of Cancerología. Recruiting at 1 site in Mexico. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by National Institute of Cancerología · Not applicable, Interventional, and Prevention
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.
What is Endometrial Cancer (EC)?
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?
How Does Obesity Affect EC Treatment?
Importance of Diet
What Patients and Families Should Know
What Healthcare Providers Should Know
General Objective:
To evaluate the metabolic effect of a physical activity and dietary intervention in patients with endometrial cancer who are candidates for staging surgery, and its association with musculoskeletal changes, in comparison with a control group of patients who do not receive the physical activity intervention.
Hypothesis Patients with endometrial cancer who engage in physical activity and follow a dietary intervention will show an increase in skeletal muscle mass, strength, and function compared to women who do not engage in physical activity. This change will be associated with a serum amino acid profile, an increase in molecules related to anabolism, a decrease in those related to catabolism, and changes in the cytokine profile indicating a trend toward reduced inflammation. Additionally, women who undergo the physical activity intervention will show improvements in glucose and lipid metabolism compared to those who do not engage in physical activity.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →National Institute of Cancerología is the lead sponsor of 38 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will only receive recommendations to follow an anti-inflammatory diet.
Other: Diet.
The intervention group will receive both dietary and exercise interventions.
Other: 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.
The comparison group will be instructed to follow the anti-inflammatory diet intervention only.
Changes in serum tyrosine concentration after the physical activity plus diet intervention, compared to patients receiving diet only.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 4 weeks.
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Cancerología