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El ensayo clínico NCT05903131 para Hiperplasia endometrial, Grade 1 Endometrial Cancer está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Uterine Preservation Via Lifestyle Transformation

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El ensayo clínico NCT05903131 está diseñado para estudiar el tratamiento de Hiperplasia endometrial, Grade 1 Endometrial Cancer. Es un estudio intervencionista de Fase II. Su estado actual es: reclutando. El ensayo se inició el 24 de octubre de 2024, con el objetivo de reclutar a 96 participantes. Dirigido por la Universidad Washington en San Luis, se espera que finalice el 31 de octubre de 2029. Los datos se actualizaron por última vez en ClinicalTrials.gov el 14 de octubre de 2025.
Resumen
Up to 60% of endometrial cancer cases are attributed to obesity, in part because obesity promotes development of atypical endometrial hyperplasia (AEH), and up to 40% of women with AEH go on to develop endometrial cancer. The increasing prevalence of obesity in premenopausal women has resulted in increasing rates of AEH in this age group. Hysterectomy with removal of the fallopian tubes and ovaries is 100% effective in preventing endometrial cancer, but this approach results in infertility. Fertility-sparing treatments exist, such as treatment with oral or intrauterine progestin, but these treatments do not work uniformly and do not combat the underlying cause of endometrial cancer, which is obesity and metabolic syndrome. Additionally, up to 41% of women on progestin eventually experience relapse of AEH or endometrial cancer. Third, many patients have insulin resistance that may worsen with progestin therapy. Thus, to improve treatment of AEH and grade 1 endometrial cancer, prevent and reverse endometrial cancer, and allow women to preserve their fertility, the investigators must integrate an effective weight loss strategy to be given with progestin treatment. It is the hypothesis that premenopausal women with AEH desire uterine preservation will be more likely to have atypia-free uterine preservation at one year if they receive progestin in combination with a behavioral weight loss intervention versus progestin plus enhanced usual care.
Título oficial

UPLifT-Endo: Uterine Preservation Via Lifestyle Transformation A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Atypical Endometrial Hyperplasia or Grade 1 Endometrial Cancer

Condiciones médicas
Hiperplasia endometrialGrade 1 Endometrial Cancer
Otros ID del ensayo
Número del NCT
NCT05903131
Inicio del ensayo (real)
2024-10-24
Última actualización
2025-10-14
Fecha de finalización (estimada)
2029-10-31
Inscripción (prevista)
96
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Reclutando
Palabras clave
fertility-sparing
weight management
obesity
endometrial cancer
behavioral intervention
premenopausal endometrial hyperplasia
premenopausal endometrial cancer
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Cruzado
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalArm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss Intervention
* The levonorgestrel-releasing IUD is used in this study as per standard care. * The behavioral weight loss intervention consists of a telemedicine cognitive behavioral coaching program. At each session, patients will self-report weight, number of days they kept a food journal during the past week, average daily caloric intake for the week, number of days exercised for the week, total number of minutes of moderate physical activity, and average number of steps per day for the week.
Telemedicine Behavioral Weight Intervention
Weekly telephone calls during the first month, biweekly during the next 5 months, and then monthly for the last 7 months (12 months total). Each telephone session will be 30 minutes long.
Progestin
Released via the levonorgestrel-releasing IUD.
Levonorgestrel-releasing IUD.
Standard of care
Comparador activoArm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual Care
* The levonorgestrel-releasing IUD is used in this study as per standard care. * Participants will be provided with 1- to 3-page handouts on topics including healthy eating, exercise, and behavioral eating strategies from materials provided on the American Cancer Society, Society of Gynecologic Oncology, and WebMD Nourish websites. These materials encourage weight loss through calorie counting, recording dietary intake, engaging in exercise programs, and using portion control strategies. * The participants randomized to this arm will cross over to the behavioral weight loss intervention arm at 12 months if they have not achieved resolution of AEH or grade 1 endometrial cancer.
Atención habitual mejorada
1-3 page handouts
Levonorgestrel-releasing IUD.
Standard of care
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy
At 1 year
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Time to resolution of atypical endometrial hyperplasia (AEH)
Defined as the period of time in months/days from the first biopsy to show AEH or grade 1 endometrial cancer to the first biopsy that shows no evidence of hyperplasia or malignancy
Through completion of follow-up (estimated to be 2 years)
Time to resolution of endometrial cancer
Through completion of follow-up (estimated to be 2 years)
Atypia-free survival
-Defined as the time interval from the date of positive treatment response (as determined by biopsy) to the date of atypical endometrial hyperplasia (AEH) recurrence. AEH-free or the patients with lost to follow-up will be censored at the last follow-up.
Through completion of follow-up (estimated to be 2 years)
Endometrial cancer progression-free survival (EC-PFS)
EC-PFS is defined as the time interval from the date of positive treatment response (as determined by biopsy) to the date of recurrence of EC. Endometrial cancer-free patients or the patients with lost to follow-up will be censored at the last follow-up.
Through completion of follow-up (estimated to be 2 years)
Change in weight
Through completion of follow-up (estimated to be 2 years)
Change in Cancer Worry Impact Events Scale (CWIES)
The CWIES is a 15-item self-report measure evaluating stress reactions and traumatic experiences, specifically inquiring about cancer worry-specific distress. Range of values for each individual item will be a Likert Scale from 0-5. 0=not at all and 5=often. The higher the score, the more cancer-worry specific distress the participant has.
At enrollment, 6 months, 12 months, end of intervention, and 24 months (estimated to be 2 years)
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Mujer

  • Diagnosis of histologically confirmed complex atypical endometrial hyperplasia (AEH) or grade 1 endometrial cancer.

    • Patients with a previous diagnosis of AEH or grade 1 endometrial cancer who are already being followed with conservative management with oral or LNG-IUD progestin therapy are eligible.
    • For patients with a previous diagnosis of AEH or grade 1 endometrial cancer who have been placed on progestin prior to study entry, the duration of IUD or oral progestin use prior to trial entry should be documented.

  • Premenopausal woman with a uterus.

  • ECOG performance status of 0-2.

  • At least 18 years of age and no more than 45 years of age.

  • Interested in uterine preservation and/or fertility-sparing treatment.

  • BMI ≥ 30 kg/m^2.

  • Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry.

  • Ability to understand and willingness to sign an IRB approved written informed consent document.

  • Current, active treatment for any malignant neoplasm with chemotherapy or radiation.
  • Pregnant and/or breastfeeding. Participants must have a negative urine or serum pregnancy test during screening window and within 7 days prior to LNG-IUD insertion. If LNG-IUD is in place, lack of pregnancy is assumed.
  • Active pelvic infection at the time of IUD placement or other contraindication to the use of an IUD in the opinion of the treating physician.
Washington University School of Medicine logoUniversidad Washington en San Luis477 ensayos clínicos activos para explorar
National Cancer Institute (NCI) logoInstituto Nacional del Corazón, los Pulmones y la Sangre, Estados Unidos3028 ensayos clínicos activos para explorar
Contactos centrales del ensayo
Contacto: Andrea R Hagemann, M.D., MSCI, 314-362-1763, [email protected]
3 Sitios del ensayo en 1 países

Missouri

Washington University School of Medicine, St Louis, Missouri, 63110, United States
Andrea R Hagemann, M.D., MSCI, Contacto, 314-362-1763, [email protected]
Andrea R Hagemann, M.D., MSCI, Investigador principal
Graham Colditz, M.D., DrPH, Subinvestigador
Ian Hagemann, M.D., Ph.D., Subinvestigador
David Mutch, M.D., Subinvestigador
Esther Lu, Ph.D., Subinvestigador
Gary Patii, Ph.D., Subinvestigador
David Morris, Ph.D., Subinvestigador
Veronica Davé, Ph.D., Subinvestigador
Reclutando

New Mexico

University of New Mexico, Albuquerque, New Mexico, 87106, United States
Carolyn Muller, M.D., Contacto, 505-272-2111
Carolyn Muller, M.D., Investigador principal
Kimberly Leslie, M.D., Subinvestigador
Reclutando

Oklahoma

University of Oklahoma, Oklahoma City, Oklahoma, 73104, United States
Kathleen Moore, M.D., MS, Contacto, 405-271-8707
Kathleen Moore, M.D., MS, Investigador principal
Reclutando