Metabolic effects of exercise and diet in women with endometrial cancer preparing for staging surgery
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.
This program will test whether a combined exercise and diet plan helps women with endometrioid endometrial cancer who are awaiting staging surgery improve muscle mass, metabolic markers, and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | National Institute of Cancerología Government |
| Locations | 1 site (México, Tlalpan) |
| Trial ID | NCT07025213 on ClinicalTrials.gov |
What this trial studies
This interventional program enrolls adult women with histologically confirmed endometrioid endometrial cancer who are candidates for staging surgery and able to attend supervised exercise sessions. Participants follow a structured physical activity regimen plus a nutritional algorithm prior to surgery, with monitoring of muscle mass and strength, metabolic and inflammatory blood markers, and patient-reported quality of life. Body composition may be evaluated using available CT imaging and functional tests, and safety is screened by ECG and standard labs. The intervention is delivered at the National Institute of Cancerología in Mexico City and compares pre- and post-intervention measures to see if the combined approach improves surgical readiness and metabolic health.
Who should consider this trial
Good fit: Women aged 18–65 with histologically confirmed endometrioid endometrial cancer, BMI >20 kg/m², no prior oncologic treatment, a normal ECG, availability for exercise sessions, and candidates for staging surgery are ideal participants.
Not a fit: Patients with advanced stage IVB disease, uncontrolled comorbidities (for example uncontrolled hypertension or significant renal dysfunction), prior or concurrent other malignancies, or who cannot participate in exercise or follow the nutritional plan are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could increase muscle mass and strength, improve metabolic and inflammation markers, and potentially reduce surgical complications and speed recovery.
How similar studies have performed: Exercise and dietary interventions have improved muscle mass, metabolic markers, and quality of life in other cancer populations, but evidence specifically focused on preoperative endometrial cancer patients is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. -Ability to understand the nature of the study and provide written informed consent. 2. -Women aged over 18 and under 65 years. 3. -Availability to attend exercise sessions. 4. -Willingness and ability to comply with scheduled visits, the proposed nutritional algorithm, treatment plan, and laboratory tests. 5. -Histologically confirmed diagnosis of endometrioid-type endometrial cancer by biopsy. 6. -Normal electrocardiogram (ECG) result. 7. -No prior oncological treatment. 8. -Body mass index (BMI) greater than 20 kg/m². 9. -Availability of a computed tomography (CT) scan. 10. -Candidates for staging surgery. Exclusion Criteria: 1. -Patients with advanced clinical stage or stage IVB disease (according to FIGO 2018 criteria). 2. -Patients with a prior or concurrent malignancy, except non-melanoma skin cancer. 3. -Patients with uncontrolled systemic arterial hypertension. 4. -Patients with renal dysfunction (eGFR ≤ 60 mL/min/1.73 m²). 5. -Patients with uncontrolled psychiatric disorders, including claustrophobia. 6. -Patients with concurrent infections. 7. -Patients with autoimmune disease. 8. -Patients with neuromuscular disease. 9. -Contraindications to physical exercise. 10. -Vulnerable situations (e.g., homelessness preventing adherence to diet, or incarceration).
Where this trial is running
México, Tlalpan
- Instituto Nacional de Cancerología — México, Tlalpan, Mexico (Recruiting)
Study contacts
- Principal investigator: Denisse Castro Eguiluz, PhD — Ministry of Science, Humanities and Technology (SECIHTI)-National Cancer Institute.
- Study coordinator: Denisse Castro Eguiluz, PhD
- Email: adcastro@secihti.mx
- Phone: +52 55 4194 0650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.