LivingGLP1
Study S000735

SHAPE-ENDO (Strategic Hormonal Approach & Prehabilitation in Endometrial Cancer): An Open-Label, Pilot Randomized Clinical Trial Comparing Standard Immediate Surgery Versus a Multimodal Metabolic Optimization and Prehabilitation Strategy Before Surgery in Patients With Atypical Endometrial Hyperplasia or Low-Risk Endometrioid Endometrial Cancer and BMI ≥40 kg/m²

ClinicalTrials.gov record

Registration

Registration
NCT07462663
Acronym
SHAPE-ENDO
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE4
Masking
NONE
Status
NOT_YET_RECRUITING
Enrollment
80
Start
2027-01
Primary completion
2031-04
Lead sponsor
Hospital Universitari de Bellvitge
Conditions
Endometrial Cancer; Endometrial Cancer Stage I; Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I; Atypical Endometrial Hyperplasia; Endometrial Intraepithelial Neoplasia; Obesity & Overweight; BMI>40; Obesity; Obesity Grade III
Interventions
DRUG:GLP-1 Receptor Agonist; DEVICE:Levonorgestrel IUD (Lng-IUD); DRUG:Oral Progestins; BEHAVIORAL:Dietetic-Nutritional intervention; BEHAVIORAL:Structured Exercise and Prehabilitation Program; PROCEDURE:Endometrial Biopsy With or Without Hysteroscopy; PROCEDURE:Radiologic Surveillance (MRI and Transvaginal Ultrasound); PROCEDURE:Standar upfront Surgery
Results posted
FALSE
Individual participant data sharing
UNDECIDED

Registered primary outcomes

  • Recruitment Rate [From study opening to end of recruitment, up to 36 months.]
  • Acceptance of Randomization Rate [At baseline, before randomization.]
  • Participant Retention Rate [From randomization to surgery and 30 days postoperatively, up to 14 months.]
  • Adherence to the Assigned Intervention [From randomization to surgery and 30 days postoperatively, up to 14 months.]
  • Completion of the SHAPE-ENDO Multimodal Strategy [From randomization to week 28 or week 54.]
  • Proportion of SHAPE-ENDO Participants Reaching Surgery Without Tumor Progression [From randomization to surgery, up to 54 weeks.]
  • Incidence of Serious Adverse Events, Tumor Progression, and Study Discontinuation [From randomization to surgery and 30 days postoperatively, up to 14 months.]

Linked records (5)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0013293Real-World Weight Loss Among Patients Initiating Semaglutide 2.4 mg and Enrolled in WeGoTogether, a Digital Self-Support Application.
Toliver JC, Advances in therapy
2025Nonrandomized studyPMID 40768192DOIregistry reference BACKGROUND:40768192
R0011750The Potential Role of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists as a Type of Conservative Treatment of Endometrial Cancer in Women of Reproductive Age: A Review of the Literature and a Call for Study.
Bourou MZ, Cureus
2024Narrative reviewPMID 39429275DOIregistry reference BACKGROUND:39429275
R0021896Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial.
Garvey WT, Nature medicine
2022Randomized trialPMID 36216945DOIregistry reference BACKGROUND:36216945
R0013102Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial.
Rubino D, JAMA
2021Randomized trialPMID 33755728DOIregistry reference BACKGROUND:33755728
R0020651Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial.
Davies M, Lancet (London, England)
2021Randomized trialPMID 33667417DOIregistry reference BACKGROUND:33667417