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SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer
Sponsor: Hospital Universitari de Bellvitge
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.
Official title: 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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
82
Start Date
2026-09
Completion Date
2028-09
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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.
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.
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
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.
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.