Trial · Interventional
Not yet recruitingPhase 4Registry dataShort name SHAPE-ENDO
1 trial · 1 not yet recruiting
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
SHAPE-ENDO is a single-center, open-label, pilot randomized clinical trial conducted at Hospital Universitari de Bellvitge in Barcelona, Spain. The study will evaluate the feasibility, safety, and acceptability of comparing two treatment strategies in women with atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or low-risk endometrioid endometrial cancer and grade III obesity, defined as BMI ≥40 kg/m². Eligible participants will be randomized in a 1:1 ratio to one of two arms. The control arm will undergo standard immediate surgery according to the institutional clinical protocol. The experimental arm will receive the SHAPE-ENDO multimodal pre-surgical optimization strategy before surgery. The SHAPE-ENDO strategy includes metabolic treatment with semaglutide/Wegovy®, local hormonal therapy with a levonorgestrel-releasing intrauterine device/Mirena® with or without oral medroxyprogesterone acetate/Progevera®, a structured nutritional program, adapted physical exercise, and scheduled oncologic surveillance with clinical evaluation, imaging, and endometrial biopsy with or without hysteroscopy. The experimental strategy will initially last 28 weeks. In participants with clinical, metabolic, or anthropometric benefit, adequate tolerance, and no evidence of tumor progression, the strategy may be extended up to 54 weeks before surgery. The primary objective is to evaluate the feasibility, safety, and acceptability of the randomized trial design. Primary feasibility outcomes include recruitment rate, acceptance of randomization, retention, adherence to the assigned intervention, completion of the SHAPE-ENDO strategy, progression during the optimization period, and the proportion of participants in the experimental arm who reach surgery without tumor progression. Secondary outcomes include perioperative morbidity, histological response in the experimental arm, metabolic and anthropometric changes, quality of life, treatment adherence, safety and tolerability, and exploratory long-term oncologic outcomes including overall survival, recurrence-free survival, and cancer-specific survival.
Active comparator
Arm A - Standard Immediate Surgery
Participants randomized to the control arm will undergo standard immediate surgical treatment according to the institutional protocol of Hospital Universitari de Bellvitge. Surgery will usually include hysterectomy with bilateral salpingo-oophorectomy, sentinel lymph node assessment when indicated and feasible, and minimally invasive or robotic approach whenever technically possible according to clinical judgment. Intervention: Procedure/Surgery - Standard Immediate Surgery Standard surgical management according to institutional practice for atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or early-stage low-risk endometrioid endometrial cancer. Perioperative outcomes, surgical approach, conversion to laparotomy, estimated blood loss, operative time, hospital stay, transfusion, sentinel lymph node detection, intraoperative complications, and 30-day postoperative complications graded according to Clavien-Dindo will be recorded.
Experimental
Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery
Participants randomized to the experimental arm will receive the SHAPE-ENDO multimodal pre-surgical optimization strategy before surgery. The strategy includes semaglutide/Wegovy®, levonorgestrel-releasing intrauterine device/Mirena® with or without oral medroxyprogesterone acetate/Progevera®, structured nutritional intervention, adapted physical exercise, and scheduled oncologic surveillance. The strategy will last 28 weeks initially and may be extended up to 54 weeks if there is clinical, metabolic, or anthropometric benefit, adequate tolerance, and no tumor progression. Intervention: Drug - Semaglutide / Wegovy® Weekly subcutaneous semaglutide administered according to approved labeling, clinical indication, tolerance, and endocrinology assessment, with standard dose escalation up to the tolerated therapeutic dose. Dose, adherence, tolerability, adverse events, and reasons for dose modification or discontinuation will be recorded. Intervention: Device - Levonorgestrel-Releasing I
Outcomes the sponsor listed as primary.
Recruitment Rate
Time frame · From study opening to end of recruitment, up to 36 months.
Number of participants enrolled per month during the active recruitment period. This outcome will assess the feasibility of recruiting eligible participants with atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or low-risk endometrioid endometrial cancer and BMI ≥40 kg/m² into a pilot randomized clinical trial.
Acceptance of Randomization Rate
Time frame · At baseline, before randomization.
Proportion of eligible participants who agree to participate in the trial and accept random assignment to either standard immediate surgery or the SHAPE-ENDO multimodal pre-surgical optimization strategy.
Participant Retention Rate
Time frame · From randomization to surgery and 30 days postoperatively, up to 14 months.
Proportion of randomized participants who complete the planned follow-up required for the main pilot analysis, including surgical treatment and 30-day postoperative assessment, or completion of the assigned intervention period when applicable.
Adherence to the Assigned Intervention
Time frame · From randomization to surgery and 30 days postoperatively, up to 14 months.
Proportion of randomized participants who comply with the main procedures planned in their assigned arm. In the control arm, this includes undergoing standard immediate surgery and postoperative follow-up. In the SHAPE-ENDO arm, this includes adherence to the multimodal strategy, scheduled visits, oncologic surveillance, and planned reassessment.
Completion of the SHAPE-ENDO Multimodal Strategy
Time frame · From randomization to week 28 or week 54.
Proportion of participants randomized to the SHAPE-ENDO arm who complete the planned multimodal pre-surgical optimization strategy until the week 28 reassessment and, when applicable, until week 54.
Proportion of SHAPE-ENDO Participants Reaching Surgery Without Tumor Progression
Time frame · From randomization to surgery, up to 54 weeks.
Proportion of participants randomized to the SHAPE-ENDO arm who undergo surgery after the pre-surgical optimization period without histological, radiological, or clinical evidence of tumor progression.
Incidence of Serious Adverse Events, Tumor Progression, and Study Discontinuation
Time frame · From randomization to surgery and 30 days postoperatively, up to 14 months.
Frequency of serious adverse events, tumor progression during the optimization period, and reasons for discontinuation or withdrawal from the study. Adverse events will be recorded prospectively and classified according to CTCAE v5.0 when applicable. These events will be described overall and by randomized arm when applicable.
Perioperative Morbidity
Time frame · At surgery and up to 30 days postoperatively.
Proportion of participants with intraoperative complications and/or clinically relevant postoperative complications within 30 days after surgery, compared between the standard immediate surgery arm and the SHAPE-ENDO arm. Postoperative complications will be classified according to the Clavien-Dindo classification, with clinically relevant complications defined as Clavien-Dindo grade ≥II
Surgical Approach
Time frame · At surgery.
Proportion of participants undergoing minimally invasive surgery, robotic surgery, conventional laparoscopy, or laparotomy, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Conversion to Laparotomy
Time frame · At surgery.
Proportion of participants requiring conversion from minimally invasive surgery to laparotomy, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Operative Time
Time frame · At surgery.
Duration of surgery measured in minutes, from skin incision to skin closure, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Estimated Blood Loss
Time frame · At surgery.
Estimated intraoperative blood loss measured in milliliters, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Length of Hospital Stay
Time frame · From surgery to hospital discharge, up to 30 days.
Number of days from surgery to hospital discharge, compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Need for Blood Transfusion
Time frame · At surgery and up to 30 days postoperatively.
Proportion of participants requiring perioperative blood transfusion, compared between the standard immediate surgery arm and the SHAPE-ENDO arm
Sentinel Lymph Node Detection Rate
Time frame · At surgery.
Proportion of participants in whom sentinel lymph node mapping is successful, including unilateral and bilateral detection rates when sentinel lymph node assessment is performed. Detection rates will be described and compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Histological Response in the SHAPE-ENDO Arm
Time frame · Baseline to week 14, week 28, and, if applicable, week 54.
Proportion of participants in the SHAPE-ENDO arm with complete response, stable disease, or tumor progression during the pre-surgical optimization period. Complete response is defined as absence of endometrioid carcinoma or atypical hyperplasia in endometrial biopsy. Stable disease is defined as persistence of the lesion without progression in grade or stage. Progression is defined as progression from atypical endometrial hyperplasia/endometrial intraepithelial neoplasia to endometrioid endometrial carcinoma, increase to grade 3, high-risk histology, or extension beyond the uterine corpus.
Time to Optimization in the SHAPE-ENDO Arm
Time frame · From randomization to week 28 or week 54
Time from randomization to multidisciplinary committee decision indicating that sufficient clinical, metabolic, anthropometric, and oncologic optimization has been achieved to proceed to surgery.
Rate of Surgery After SHAPE-ENDO Optimization
Time frame · From randomization to surgery, up to 54 weeks.
Proportion of participants randomized to the SHAPE-ENDO arm who undergo surgery after the pre-surgical optimization strategy.
Change in Glycated Hemoglobin
Time frame · Baseline to 6 months and baseline to 12 months.
Change from baseline in glycated hemoglobin, measured as HbA1c percentage using standard clinical laboratory assays. Changes over time will be described within each arm and compared between the standard immediate surgery arm and the SHAPE-ENDO arm.
Change in Fasting Plasma Glucose
Time frame · Baseline to 6 months and baseline to 12 months.
Change from baseline in fasting plasma glucose concentration, measured in mg/dL using standard laboratory assays. Changes over time will be described within each arm and compared between both randomized arms.
Change in Insulinemia and HOMA-IR
Time frame · Baseline to 6 months and baseline to 12 months.
Change from baseline in fasting insulin concentration and HOMA-IR, when available. Changes over time will be described within each arm and compared between both randomized arms.
Change in FIB-4 Index
Time frame · Baseline to 6 months and baseline to 12 months.
Change from baseline in fibrosis-4 index, calculated using age, AST, ALT, and platelet count. Changes over time will be described within each arm and compared between both randomized arms.
Change in Lipid Profile
Time frame · Baseline to 6 months and baseline to 12 months.
Change from baseline in triglycerides, LDL cholesterol, and HDL cholesterol measured using standard laboratory lipid panel testing. Changes over time will be described within each arm and compared between both randomized arms.
Change in Blood Pressure
Time frame · Baseline to 6 months and baseline to 12 months.
Change from baseline in systolic and diastolic blood pressure, measured in mmHg during scheduled clinical visits. Changes over time will be described within each arm and compared between both randomized arms.
Change in C-Reactive Protein
Time frame · Baseline to 6 months and baseline to 12 months.
Change from baseline in serum C-reactive protein concentration, measured in mg/L using standard laboratory assays. Changes over time will be described within each arm and compared between both randomized arms.
Change in Body Weight and BMI
Time frame · Baseline to 6 months and baseline to 12 months.
Absolute and percentage change from baseline in body weight and body mass index. Changes over time will be described within each arm and compared between both randomized arms.
Change in Waist Circumference
Time frame · Baseline to 6 months and baseline to 12 months.
Change from baseline in waist circumference, measured in centimeters. Changes over time will be described within each arm and compared between both randomized arms.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
3 studies on this page
Indexing hint: Randomized controlled trial · 2022
Garvey et al. 2022Nature medicinecited by 672
PMID 36216945PMC9556320DOI 10.1038/s41591-022-02026-4PUB-36216945
Indexing hint: Randomized controlled trial · 2021
Davies et al. 2021Lancet (London, England)cited by 1,104
PMID 33667417DOI 10.1016/s0140-6736(21)00213-0PUB-33667417
Indexing hint: Randomized controlled trial · 2021
Rubino et al. 2021JAMAcited by 1,095
PMID 33755728PMC7988425DOI 10.1001/jama.2021.3224PUB-33755728
1 study on this page
PubMed tag: none · 2025
Toliver et al. 2025Advances in therapycited by 2
PMID 40768192PMC12474656DOI 10.1007/s12325-025-03325-1PUB-40768192
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated