Trials / Not Yet Recruiting

Not Yet RecruitingNCT07462663

SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer

SHAPE-ENDO (Strategic Hormonal Approach & Prehabilitation in Endometrial Cancer): Prospective Observational Study for Metabolic and Surgical Optimization in Patients With Atypical Endometrial Hyperplasia or Early-stage Endometrial Cancer and BMI ≥35.

Status: Not Yet Recruiting
Phase: —
Study type: Observational
Enrollment: 82 (estimated)

Sponsor: Hospital Universitari de Bellvitge · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

SHAPE-ENDO is a prospective observational study conducted at Hospital Universitari de Bellvitge evaluating a multimodal pre-surgical optimization strategy for women with obesity (BMI ≥35) and atypical endometrial hyperplasia or early-stage endometrial cancer. Participants receive standard-of-care interventions including GLP1 RA therapy, levonorgestrel intrauterine device (with or without oral progestins), structured nutrition and exercise programs, and scheduled endometrial surveillance. The study aims to assess whether this multimodal strategy improves metabolic health, promotes weight loss, and increases eligibility for minimally invasive surgery while maintaining oncologic safety during the optimization period. Participants are followed for 12 months with monitoring of anthropometric and metabolic parameters, histological response, quality of life, and treatment adherence. All interventions are part of routine clinical care. Findings from this study may inform future comparative trials evaluating metabolic optimization strategies in patients with obesity and early-stage endometrial cancer.

Detailed description

Obesity is a major risk factor for endometrial cancer and is associated with increased surgical complexity, perioperative morbidity, and reduced eligibility for minimally invasive surgery. In patients with severe obesity, mortality is frequently influenced by metabolic comorbidities rather than cancer progression. Strategies aimed at improving metabolic health and functional status prior to surgery may therefore have important clinical implications. Hormonal therapies such as the levonorgestrel-releasing intrauterine device and systemic progestins are commonly used for disease control in selected patients with atypical endometrial hyperplasia or early-stage endometrioid carcinoma. In parallel, GIP/glucagon-like peptide-1 receptor agonists, including semaglutide or terzipatide, have demonstrated significant weight loss and cardiometabolic benefits. Multimodal prehabilitation approaches combining pharmacologic therapy, nutritional optimization, and structured exercise programs may improve surgical readiness and overall health status. SHAPE-ENDO is a prospective observational cohort study conducted at Hospital Universitari de Bellvitge. The study evaluates a multimodal pre-surgical optimization strategy that includes pharmacologic weight management with semaglutide, hormonal endometrial treatment with levonorgestrel intrauterine device with or without oral progestins, and lifestyle interventions including supervised dietary counseling and exercise programs. Patients undergo scheduled clinical follow-up with metabolic monitoring, imaging, and endometrial sampling according to routine clinical practice. The study aims to evaluate the feasibility and clinical impact of this multimodal optimization strategy in women with obesity and early-stage endometrial disease. Outcomes include metabolic and anthropometric changes, histological response, quality of life, and eligibility for minimally invasive surgery. Data are collected through electronic medical records, laboratory testing, imaging studies, and validated patient-reported outcome questionnaires. The study is approved by the institutional ethics committee and involves only standard-of-care interventions.

Conditions

Interventions

Type	Name	Description
DRUG	semaglutide	Weekly subcutaneous semaglutide titrated up to 2.4 mg according to routine clinical practice to support weight loss and metabolic optimization in patients with BMI ≥35. The medication is not assigned experimentally; it is prescribed by the treating endocrinology team as part of standard care. Data on dosing, tolerance, and adherence are collected prospectively for observational analysis.
DEVICE	Levonorgestrel IUD (Lng-IUD)	Local hormonal therapy using a levonorgestrel-releasing intrauterine device placed as part of standard clinical management for atypical endometrial hyperplasia or low-risk endometrioid carcinoma. Device insertion occurs at baseline or within 14 days, with ultrasound confirmation of placement. This treatment is not assigned experimentally; it is provided based on routine clinical criteria, and data on tolerability, continuation, and local response are collected prospectively.
DRUG	Oral Progestins	Systemic hormonal therapy prescribed according to clinical criteria to support local disease control in atypical endometrial hyperplasia or early-stage endometrioid carcinoma. Typical regimens include medroxyprogesterone acetate (400-600 mg/day) or megestrol acetate (160-320 mg/day). Therapy is initiated or escalated when indicated based on tumor burden or suboptimal response to LNG-IUD. These medications are not assigned experimentally; they are standard-of-care treatments, and their use, dosing, tolerance, and outcomes are recorded prospectively.
BEHAVIORAL	Dietetic-Nutritional intervention	Personalized hypocaloric diet plan supervised by the clinical nutrition team as part of standard obesity and metabolic management. The program includes caloric restriction based on basal metabolic requirements, with the option of very low-calorie diets (VLCD) for 4-6 weeks in selected cases. Follow-up occurs at regular outpatient visits with recording of weight, BMI, waist circumference, and adherence. This intervention is part of routine clinical care and not assigned experimentally; outcomes are recorded prospectively.
BEHAVIORAL	Structured Exercise and Prehabilitation Program	A structured physical exercise program designed to improve functional capacity, aerobic tolerance, and surgical fitness. Program includes supervised or semi-supervised weekly sessions combining aerobic and strength training, typically 3 sessions per week for 30-45 minutes, adapted to baseline performance. The intervention is part of routine clinical care for patients with obesity undergoing surgical preparation and is not assigned experimentally. Data on adherence, tolerance, and functional outcomes are collected prospectively
PROCEDURE	Endometrial Biopsy With or Without Hysteroscopy	Scheduled histological surveillance performed at baseline and at follow-up intervals (typically 14 and 28-54 weeks) to assess local tumor status, including complete response, stability, or progression. Procedures include outpatient endometrial biopsy with optional hysteroscopy based on clinical indication. These evaluations form part of standard clinical care in patients managed conservatively for atypical endometrial hyperplasia or early-stage endometrioid carcinoma and are not assigned experimentally. Data are recorded prospectively to assess disease evolution and surgical eligibility.
PROCEDURE	Radiologic Surveillance (MRI and Transvaginal Ultrasound)	Radiologic evaluation using pelvic MRI and transvaginal ultrasound performed as part of routine clinical care to assess uterine disease, myometrial invasion, adnexal status, and treatment response. Imaging is typically performed at baseline to confirm staging and during follow-up when clinically indicated. These imaging modalities are used per standard clinical guidelines and are not assigned experimentally; results are collected prospectively to evaluate disease stability and surgical planning.

Timeline

Start date: 2026-09-01
Primary completion: 2027-05-01
Completion: 2028-09-01
First posted: 2026-03-10
Last updated: 2026-04-09

Source: ClinicalTrials.gov record NCT07462663. Inclusion in this directory is not an endorsement.