Endometrial CancerNCT07025213
Metabolic Effect of Exercise and Diet in Endometrial Cancer Patients Eligible for Staging Surgery.
A study testing Diet and exercise. and Diet. in people with Endometrial Cancer, run by National Institute of Cancerología at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Diet and exercise. and Diet.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 2 Apr 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
Show all 10Show fewer
- -No prior oncological treatment.
- -Body mass index (BMI) greater than 20 kg/m².
- -Availability of a computed tomography (CT) scan.
- -Candidates for staging surgery.
Who cannot join
- -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.
Show all 10Show fewer
- -Patients with autoimmune disease.
- -Patients with neuromuscular disease.
- -Contraindications to physical exercise.
- -Vulnerable situations (e.g., homelessness preventing adherence to diet, or incarceration).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cancerología
México, Tlalpan, 14080
Denisse Castro Eguiluz, PhD, +52 55 4194 0650, adcastro@secihti.mx
Julissa Luvián Morales, PhD, +52 556 934 7316, juli.luvian.morales@gmail.com
About this study
Official title: 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.
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).
Read more
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.
Read the detailed description
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?
- Being overweight or obese is a major risk factor because fat tissue produces estrogen, which can fuel the cancer.
- Other risks include diabetes, high blood pressure, and lack of physical activity.
- Obesity causes chronic inflammation in the body, creating an environment that supports cancer growth.
- What is Sarcopenia and Sarcopenic Obesity?
- Sarcopenia means losing muscle strength and mass, often due to aging or diseases like cancer.
- Sarcopenic obesity is when someone has both excess fat and low muscle, which is linked to worse health outcomes in cancer patients.
- In EC patients, sarcopenia and obesity together can make treatment harder and lower survival rates.
How Does Obesity Affect EC Treatment?
- Obesity increases surgical risks and can limit treatment options.
- Patients with good muscle mass before surgery tend to recover better and live longer.
- Comorbidities (like diabetes or heart disease) common in obesity can complicate cancer treatment.
- Role of Physical Activity
- Exercise is very beneficial for people with EC, obesity, and sarcopenia.
- Aerobic (cardio) exercise helps reduce fat, especially around organs.
- Resistance (strength) training helps build muscle mass and improve strength.
- Exercise can reduce inflammation, improve metabolism, and enhance quality of life.
- For cancer patients, staying active helps manage side effects, improve treatment tolerance, and reduce fatigue.
Importance of Diet
- A healthy diet rich in fruits, vegetables, whole grains, healthy fats, and protein supports weight management and muscle health.
- Avoid diets high in sugar, unhealthy fats, and processed foods, which contribute to obesity and inflammation.
- Nutritional support should start at diagnosis to improve treatment outcomes and overall health.
What Patients and Families Should Know
- Maintaining a healthy weight and staying physically active can reduce the risk of EC and improve outcomes if diagnosed.
- Muscle strength and nutrition are very important during cancer treatment.
- Work with healthcare providers to develop a plan that includes diet, physical activity, and medical treatment tailored to individual needs.
- Early detection and timely treatment improve prognosis.
What Healthcare Providers Should Know
- Screen for obesity, diabetes, hypertension, and sarcopenia in patients with or at risk for EC.
- Counsel patients on the benefits of physical activity and healthy eating.
- Consider multidisciplinary care involving nutritionists, physical therapists, and oncologists.
- Monitor muscle mass and function as part of cancer care to improve surgical and treatment outcomes.
- Tailor treatment plans considering the patient's physical condition and comorbidities.
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.
- Conditions
- Endometrial Cancer
- Being tested
- Diet and exercise., Diet.
- Keywords
- excercise, muscle mass and strength, Metabolism changes, inflammation biomarkers, quality of life, surgical complication
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and exercise.Other
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.Other
The comparison group will be instructed to follow the anti-inflammatory diet intervention only.
| Study group | Role | What they receive |
|---|---|---|
| Diet. | Active comparator | This group will only receive recommendations to follow an anti-inflammatory diet. Receives: Other: Diet. |
| Diet and exercise. | Experimental | The intervention group will receive both dietary and exercise interventions. Receives: Other: Diet and exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum tyrosine concentration after the physical activity plus diet intervention, compared to patients receiving diet only.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start2 Apr 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, two-arm pilot study in adult women diagnosed with endometrial cancer and candidates for staging surgery.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cancerología
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lucely Cetina Pérez, National Institute of Cancerología
- Investigators
- Denisse Castro Eguiluz, PhD, Principal investigator, Ministry of Science, Humanities and Technology (SECIHTI)-National Cancer Institute.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025213
- Sponsor's protocol ID
- (024/046/ICI)(CEI/041/24)
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07025213
- Acronym / sponsor ID
- (024/046/ICI)(CEI/041/24)
- Conditions
- Endometrial Cancer
- Keywords
- excercise, muscle mass and strength, Metabolism changes, inflammation biomarkers, quality of life, surgical complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Institute of CancerologíaOther government
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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?
- Being overweight or obese is a major risk factor because fat tissue produces estrogen, which can fuel the cancer.
- Other risks include diabetes, high blood pressure, and lack of physical activity.
- Obesity causes chronic inflammation in the body, creating an environment that supports cancer growth.
- What is Sarcopenia and Sarcopenic Obesity?
- Sarcopenia means losing muscle strength and mass, often due to aging or diseases like cancer.
- Sarcopenic obesity is when someone has both excess fat and low muscle, which is linked to worse health outcomes in cancer patients.
- In EC patients, sarcopenia and obesity together can make treatment harder and lower survival rates.
How Does Obesity Affect EC Treatment?
- Obesity increases surgical risks and can limit treatment options.
- Patients with good muscle mass before surgery tend to recover better and live longer.
- Comorbidities (like diabetes or heart disease) common in obesity can complicate cancer treatment.
- Role of Physical Activity
- Exercise is very beneficial for people with EC, obesity, and sarcopenia.
- Aerobic (cardio) exercise helps reduce fat, especially around organs.
- Resistance (strength) training helps build muscle mass and improve strength.
- Exercise can reduce inflammation, improve metabolism, and enhance quality of life.
- For cancer patients, staying active helps manage side effects, improve treatment tolerance, and reduce fatigue.
Importance of Diet
- A healthy diet rich in fruits, vegetables, whole grains, healthy fats, and protein supports weight management and muscle health.
- Avoid diets high in sugar, unhealthy fats, and processed foods, which contribute to obesity and inflammation.
- Nutritional support should start at diagnosis to improve treatment outcomes and overall health.
What Patients and Families Should Know
- Maintaining a healthy weight and staying physically active can reduce the risk of EC and improve outcomes if diagnosed.
- Muscle strength and nutrition are very important during cancer treatment.
- Work with healthcare providers to develop a plan that includes diet, physical activity, and medical treatment tailored to individual needs.
- Early detection and timely treatment improve prognosis.
What Healthcare Providers Should Know
- Screen for obesity, diabetes, hypertension, and sarcopenia in patients with or at risk for EC.
- Counsel patients on the benefits of physical activity and healthy eating.
- Consider multidisciplinary care involving nutritionists, physical therapists, and oncologists.
- Monitor muscle mass and function as part of cancer care to improve surgical and treatment outcomes.
- Tailor treatment plans considering the patient's physical condition and comorbidities.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, two-arm pilot study in adult women diagnosed with endometrial cancer and candidates for staging surgery.
| Arm | Type | Receives |
|---|---|---|
| Diet. | Active comparator | Other: Diet.This group will only receive recommendations to follow an anti-inflammatory diet. |
| Diet and exercise. | Experimental | Other: Diet and exercise.The intervention group will receive both dietary and exercise interventions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- -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.
Key exclusion criteria (10 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Diet and exercise. |
| Diet.The comparison group will be instructed to follow the anti-inflammatory diet intervention only. | Other | Diet. |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Denisse Castro Eguiluz, PhD principal investigator
Ministry of Science, Humanities and Technology (SECIHTI)-National Cancer Institute.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and exercise. and Diet. in people with Endometrial Cancer, run by National Institute of Cancerología at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denisse Castro Eguiluz, PhD (+52 55 4194 0650, adcastro@secihti.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.