SHAPE-ENDO: Pilot Randomized Trial of Multimodal Pre-Surgical Optimization Versus Standard Surgery in Patients With Obesity and Early-Stage Endometrial Cancer

NCT07462663 | Not Yet Recruiting Phase 4

• 1 other identifier: SHAPE-ENDO
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Endometrial Cancer; Endometrial Intraepithelial Neoplasia; Obesity & Overweight; Endometrial Cancer Stage I; Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I; Atypical Endometrial Hyperplasia; Obesity; BMI>40; Obesity Grade III

Keywords

Semaglutide; GLP-1 receptor agonist; levonorgestrel IUD; hormonal therapy; prehabilitation; minimally invasive surgery; robotic surgery; metabolic optimization; endometrial hyperplasia; weight loss intervention; endometrial cancer; endometrial carcinoma; early stage; obesity; cancer; real-world evidence; prospective; ClinicalTrial; wegovy

Outcome Measures

Primary Outcomes (7)

• Recruitment Rate

  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.

  From study opening to end of recruitment, up to 36 months.

• Acceptance of Randomization Rate

  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.

  At baseline, before randomization.

• Participant Retention Rate

  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.

  From randomization to surgery and 30 days postoperatively, up to 14 months.

• Adherence to the Assigned Intervention

  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.

  From randomization to surgery and 30 days postoperatively, up to 14 months.

• Completion of the SHAPE-ENDO Multimodal Strategy

  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.

  From randomization to week 28 or week 54.

• Proportion of SHAPE-ENDO Participants Reaching Surgery Without Tumor Progression

  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.

  From randomization to surgery, up to 54 weeks.

• Incidence of Serious Adverse Events, Tumor Progression, and Study Discontinuation

  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.

  From randomization to surgery and 30 days postoperatively, up to 14 months.

Secondary Outcomes (27)

• Perioperative Morbidity

  At surgery and up to 30 days postoperatively.

• Surgical Approach

  At surgery.

• Conversion to Laparotomy

  At surgery.

• Operative Time

  At surgery.

• Estimated Blood Loss

  At surgery.

Study Arms (2)

Arm A - Standard Immediate Surgery

ACTIVE COMPARATOR

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.

Procedure: Standar upfront Surgery

Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery

EXPERIMENTAL

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

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)

Interventions

Standar upfront Surgery PROCEDURE

Standard surgical treatment according to the institutional protocol of Hospital Universitari de Bellvitge for atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or early-stage low-risk endometrioid endometrial cancer. Surgery will usually include hysterectomy with bilateral salpingo-oophorectomy, sentinel lymph node assessment when indicated and feasible, and a minimally invasive or robotic approach whenever technically possible according to clinical judgment. Surgical approach, operative time, estimated blood loss, conversion to laparotomy, transfusion, hospital stay, intraoperative complications, 30-day postoperative complications, readmission, and sentinel lymph node detection will be recorded.

Also known as: Standard Surgery, BSO, Hysterectomy, Upfront Surgery

Arm A - Standard Immediate Surgery

Levonorgestrel IUD (Lng-IUD) DEVICE

Local hormonal therapy using a 52-mg levonorgestrel-releasing intrauterine system placed at baseline or within 14 days after baseline, with ultrasound confirmation of correct placement. The LNG-IUD is used within the protocolized SHAPE-ENDO strategy according to clinical indication, approved labeling, current guidelines, and physician judgment, for local disease control in atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or early-stage, low-risk endometrioid endometrial cancer. Tolerability, continuation, adverse events, and local histological response will be recorded prospectively.

Also known as: LNG-IUD

Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery

Dietetic-Nutritional intervention BEHAVIORAL

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.

Also known as: Hypocaloric diet program, Nutritional Counseling, Dietary Prehabiilitation

Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery

Structured Exercise and Prehabilitation Program BEHAVIORAL

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

Also known as: Exercise Prehabilitation, Supervised Physical Activity Program, Combined Aerobic and Strength Training

Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery

Oral Progestins DRUG

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. Oral progestins may be used within the protocolized SHAPE-ENDO strategy according to clinical indication, approved labeling, current guidelines, and physician judgment. Use, dosing, tolerance, and outcomes will be recorded prospectively.

Also known as: Medroxyprogesterone acetate, Megestrol acetate, Progestin therapy

Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery

Radiologic Surveillance (MRI and Transvaginal Ultrasound) PROCEDURE

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.

Also known as: Pelvic MRI, Transvaginal Ultrasound, Imaging Surveillance

Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery

GLP-1 Receptor Agonist DRUG

Weekly subcutaneous semaglutide/GLP-1 receptor agonist therapy administered according to approved labeling, clinical indication, patient tolerance, and endocrinology assessment, with standard dose escalation up to the tolerated therapeutic dose. The intervention is used for weight loss and metabolic optimization in participants with severe obesity. Dose, adherence, tolerability, and reasons for dose modification or discontinuation will be recorded prospectively.

Also known as: Semaglutide

Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery

Endometrial Biopsy With or Without Hysteroscopy PROCEDURE

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.

Also known as: Histological Surveillance, Endometrial Sampling, Hysteroscopy

Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants ≥18 years old.
• Histologically confirmed atypical endometrial hyperplasia/endometrial intraepithelial neoplasia (AEH/EIN) or low-risk endometrioid endometrial carcinoma, grade 1 or 2.
• Disease apparently confined to the uterine corpus, assessed by expert transvaginal ultrasound and/or pelvic magnetic resonance imaging.
• Low- or intermediate-risk disease according to ESGO-ESTRO-ESP 2025 criteria, including presurgical stages IA1, IA2, or IB.
• Negative or focal lymphovascular space invasion, if available.
• Favorable molecular profile, if available, including POLE-mutated, p53 wild-type, MMR-deficient, or NSMP estrogen receptor-positive disease.
• Considered a candidate for surgical treatment by the multidisciplinary tumor board.
• Ability to understand and sign written informed consent after receiving oral and written information about the study, including acceptance of random assignment to either standard immediate surgery or the SHAPE-ENDO multimodal pre-surgical optimization strategy.

You may not qualify if:

• FIGO stage IA3, IC, II, or higher disease.
• Extensive lymphovascular space invasion, if available.
• High-risk molecular profile, including p53-abnormal/mutated disease or NSMP estrogen receptor-negative disease.
• Non-endometrioid histology, including serous carcinoma, clear-cell carcinoma, carcinosarcoma, mixed histology, or other high-risk histological subtypes.
• Metastatic disease or suspicion of extrauterine disease.
• Considered medically inoperable or "unfit" for surgery because of severe comorbidity, frailty, anesthetic contraindication, or any other clinical reason contraindicating surgical treatment.
• Contraindication to GLP-1 receptor agonist therapy or progestin-based hormonal therapy, including levonorgestrel-releasing intrauterine device or oral progestins.
• Previous pancreatitis, medullary thyroid carcinoma, or multiple endocrine neoplasia type 2.
• Concurrent participation in another interventional pharmacological clinical trial.
• Any condition that, in the investigator's judgment, may compromise participant safety, interfere with protocol compliance, or make participation inappropriate.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• University of Barcelona: collaborator

Related Publications (19)

• Concin N, Matias-Guiu X, Cibula D, Colombo N, Creutzberg CL, Ledermann J, Mirza MR, Vergote I, Abu-Rustum NR, Bosse T, Chargari C, Espenel S, Fagotti A, Fotopoulou C, Gatius S, Gonzalez-Martin A, Lax S, Levy B, Lorusso D, Macchia G, Marth C, Morice P, Oaknin A, Raspollini MR, Schwameis R, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Planchamp F, Nout RA. ESGO-ESTRO-ESP guidelines for the management of patients with endometrial carcinoma: update 2025. Lancet Oncol. 2025 Aug;26(8):e423-e435. doi: 10.1016/S1470-2045(25)00167-6.

  PMID: 40744042 BACKGROUND

• Iavazzo C, Gkegkes ID. Conservative management of patients with endometrial intraepithelial neoplasia (EIN): Factors that could affect response and pregnancy rates. Turk J Med Sci. 2022 Jun;52(3):870. doi: 10.55730/1300-0144.5384. Epub 2022 Jun 16. No abstract available.

  PMID: 36326317 BACKGROUND

• Cui J, Zhao YC, She LZ, Wang TJ. Comparative effects of progestin-based combination therapy for endometrial cancer or atypical endometrial hyperplasia: a systematic review and network meta-analysis. Front Oncol. 2024 May 3;14:1391546. doi: 10.3389/fonc.2024.1391546. eCollection 2024.

  PMID: 38764577 BACKGROUND

• Laurelli G, Falcone F, Gallo MS, Scala F, Losito S, Granata V, Cascella M, Greggi S. Long-Term Oncologic and Reproductive Outcomes in Young Women With Early Endometrial Cancer Conservatively Treated: A Prospective Study and Literature Update. Int J Gynecol Cancer. 2016 Nov;26(9):1650-1657. doi: 10.1097/IGC.0000000000000825.

  PMID: 27654262 BACKGROUND

• Fan Z, Li H, Hu R, Liu Y, Liu X, Gu L. Fertility-Preserving Treatment in Young Women With Grade 1 Presumed Stage IA Endometrial Adenocarcinoma: A Meta-Analysis. Int J Gynecol Cancer. 2018 Feb;28(2):385-393. doi: 10.1097/IGC.0000000000001164.

  PMID: 29266019 BACKGROUND

• Marnach ML, Butler KA, Henry MR, Hutz CE, Langstraat CL, Lohse CM, Casey PM. Oral Progestogens Versus Levonorgestrel-Releasing Intrauterine System for Treatment of Endometrial Intraepithelial Neoplasia<sup/> J Womens Health (Larchmt). 2017 Apr;26(4):368-373. doi: 10.1089/jwh.2016.5774. Epub 2016 Nov 30.

  PMID: 27901412 BACKGROUND

• Bourou MZ, Matsas A, Valsamakis G, Vlahos N, Panoskaltsis T. The 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. Cureus. 2024 Sep 18;16(9):e69678. doi: 10.7759/cureus.69678. eCollection 2024 Sep.

  PMID: 39429275 BACKGROUND

• Toliver JC, Divino V, Ng CD, Wang J. Real-World Weight Loss Among Patients Initiating Semaglutide 2.4 mg and Enrolled in WeGoTogether, a Digital Self-Support Application. Adv Ther. 2025 Oct;42(10):5010-5022. doi: 10.1007/s12325-025-03325-1. Epub 2025 Aug 6.

  PMID: 40768192 BACKGROUND

• Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Wharton S; STEP 5 Study Group. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022 Oct;28(10):2083-2091. doi: 10.1038/s41591-022-02026-4. Epub 2022 Oct 10.

  PMID: 36216945 BACKGROUND

• Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, Lingvay I, Mosenzon O, Rosenstock J, Rubio MA, Rudofsky G, Tadayon S, Wadden TA, Dicker D; STEP 4 Investigators. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1414-1425. doi: 10.1001/jama.2021.3224.

  PMID: 33755728 BACKGROUND

• Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. Semaglutide 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. Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.

  PMID: 33667417 BACKGROUND

• von Gruenigen VE, Tian C, Frasure H, Waggoner S, Keys H, Barakat RR. Treatment effects, disease recurrence, and survival in obese women with early endometrial carcinoma : a Gynecologic Oncology Group study. Cancer. 2006 Dec 15;107(12):2786-91. doi: 10.1002/cncr.22351.

  PMID: 17096437 BACKGROUND

• Vargiu V, Rosati A, Capozzi VA, Sozzi G, Gioe A, Berretta R, Chiantera V, Scambia G, Fanfani F, Cosentino F. Impact of Obesity on Sentinel Lymph Node Mapping in Patients with apparent Early-Stage Endometrial Cancer: The ObeLyX study. Gynecol Oncol. 2022 May;165(2):215-222. doi: 10.1016/j.ygyno.2022.03.003. Epub 2022 Mar 18.

  PMID: 35314087 BACKGROUND

• Habo YK, Habo NK, Elsayed AAR, Basson MD. Risk factors for postoperative complications following hysterectomy in endometrial cancer patients: A systematic review. J Gynecol Obstet Hum Reprod. 2025 Sep;54(7):102964. doi: 10.1016/j.jogoh.2025.102964. Epub 2025 Apr 30.

  PMID: 40316173 BACKGROUND

• Akesson A, Wolmesjo N, Adok C, Milsom I, Dahm-Kahler P. Lymphadenectomy, obesity and open surgery are associated with surgical complications in endometrial cancer. Eur J Surg Oncol. 2021 Nov;47(11):2907-2914. doi: 10.1016/j.ejso.2021.06.034. Epub 2021 Jul 1.

  PMID: 34238643 BACKGROUND

• Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645.

  PMID: 30193337 BACKGROUND

• Concin N, Matias-Guiu X, Vergote I, Cibula D, Mirza MR, Marnitz S, Ledermann J, Bosse T, Chargari C, Fagotti A, Fotopoulou C, Gonzalez Martin A, Lax S, Lorusso D, Marth C, Morice P, Nout RA, O'Donnell D, Querleu D, Raspollini MR, Sehouli J, Sturdza A, Taylor A, Westermann A, Wimberger P, Colombo N, Planchamp F, Creutzberg CL. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma. Int J Gynecol Cancer. 2021 Jan;31(1):12-39. doi: 10.1136/ijgc-2020-002230. Epub 2020 Dec 18.

  PMID: 33397713 BACKGROUND

• Gallos ID, Yap J, Rajkhowa M, Luesley DM, Coomarasamy A, Gupta JK. Regression, relapse, and live birth rates with fertility-sparing therapy for endometrial cancer and atypical complex endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2012 Oct;207(4):266.e1-12. doi: 10.1016/j.ajog.2012.08.011. Epub 2012 Aug 10.

  PMID: 23021687 BACKGROUND

• Aune D, Navarro Rosenblatt DA, Chan DS, Vingeliene S, Abar L, Vieira AR, Greenwood DC, Bandera EV, Norat T. Anthropometric factors and endometrial cancer risk: a systematic review and dose-response meta-analysis of prospective studies. Ann Oncol. 2015 Aug;26(8):1635-48. doi: 10.1093/annonc/mdv142. Epub 2015 Mar 19.

  PMID: 25791635 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms; Endometrial Hyperplasia; Obesity; Overweight; Neoplasms

Interventions

semaglutide; Progestins; Medroxyprogesterone Acetate; Megestrol Acetate; Estrogen Replacement Therapy; Nutrition Assessment; Resistance Training; Hysteroscopy; Magnetic Resonance Spectroscopy; Hysterectomy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Megestrol; Pregnadienes; Hormone Replacement Therapy; Drug Therapy; Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Jorge Garcia Fernandez

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

• Lola Marti

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Garcia Fernandez, MD

CONTACT

+34 622595644; jorgarciafernan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be performed because of the nature of the interventions. Participants and investigators will know the assigned treatment strategy..
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Gynaecology and Obstetrics

Model Details: Open-label, pilot randomized clinical trial with two parallel arms. Eligible participants will be randomized in a 1:1 ratio to standard immediate surgery or to the SHAPE-ENDO multimodal pre-surgical optimization strategy followed by surgery. The pilot trial is designed to evaluate feasibility, safety, acceptability, and preliminary efficacy signals to inform a future confirmatory trial.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: March 10, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): January 1, 2035
• Last Updated: June 10, 2026

Record last verified: 2026-06