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

NCT07025213 | Recruiting DMC

• 1 other identifier: (024/046/ICI)(CEI/041/24)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Keywords

excercise; muscle mass and strength; Metabolism changes; inflammation biomarkers; quality of life; surgical complication

Outcome Measures

Primary Outcomes (34)

• 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.

Study Arms (2)

Diet.

ACTIVE COMPARATOR

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

Other: Diet.

Diet and exercise.

EXPERIMENTAL

The intervention group will receive both dietary and exercise interventions.

Other: Diet and exercise.

Interventions

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 and exercise.

Diet. OTHER

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

Diet.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Cancerología: lead

Study Sites (1)

Instituto Nacional de Cancerología

México, Tlalpan, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Denisse Castro Eguiluz, PhD

  Ministry of Science, Humanities and Technology (SECIHTI)-National Cancer Institute.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denisse Castro Eguiluz, PhD

CONTACT

+52 55 4194 0650; adcastro@secihti.mx

Julissa Luvián Morales, PhD

CONTACT

+52 556 934 7316; juli.luvian.morales@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Open-label, two-arm pilot study in adult women diagnosed with endometrial cancer and candidates for staging surgery.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 17, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)