SHAPE-ENDO is a prospective, single-center, observational cohort study conducted at Hospital Universitari de Bellvitge (Barcelona, Spain), designed to evaluate a multimodal pre-surgical optimization strategy in women with severe obesity (BMI ≥40 kg/m²) and atypical endometrial hyperplasia or early-stage, low-risk endometrial cancer. This strategy reflects current clinical practice in selected patients in whom immediate surgery may be associated with increased perioperative risk due to obesity and comorbidities. Instead of upfront surgery, patients undergo a structured optimization program aimed at improving metabolic status while maintaining local oncologic control. The multimodal intervention includes standard-of-care treatments: * Pharmacological metabolic therapy with glucagon-like peptide-1 receptor agonists (GLP-1 RAs, e.g., semaglutide) or dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonists (GIP/GLP-1 RAs, e.g., tirzepatide), according to clinical indication and availability * Local hormonal treatment with a levonorgestrel-releasing intrauterine device (LNG-IUD), with or without oral progestins * Structured nutritional intervention * Supervised physical exercise program * Scheduled clinical, imaging, and histological surveillance The study is structured in two phases: Phase 1 (prospective cohort phase): Participants are followed during a 28-54 week prehabilitation period to evaluate the proportion of patients achieving predefined optimization criteria, including significant weight loss, improved metabolic status, adequate anesthetic risk profile, and absence of tumor progression. Secondary outcomes include histological response, treatment adherence, quality of life, and feasibility of subsequent surgical management. Phase 2 (long-term follow-up and comparative phase): Participants from the prospective cohort will be followed longitudinally for a minimum of 5 years to assess overall survival, disease-specific survival, recurrence rates, long-term metabolic outcomes, and quality of life. In addition, outcomes will be compared with a historical cohort of patients with similar baseline characteristics (BMI ≥40 kg/m²) previously treated at the same institution, with particular focus on surgical morbidity and survival outcomes. All interventions are part of routine clinical care and are administered according to current clinical guidelines and physician judgment. The primary objective of the study is to evaluate whether this multimodal strategy can improve surgical eligibility and reduce perioperative risk without compromising oncologic safety, while potentially impacting long-term survival and quality of life in this high-risk population. Findings from SHAPE-ENDO may provide evidence to support a paradigm shift toward integrated metabolic and oncologic management in patients with obesity and early-stage endometrial cancer, and may inform future controlled comparative studies.
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Proportion of patients achieving predefined metabolic and clinical optimization criteria
Timeframe: Up to 12 months