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Clinical Trial NCT05903131 for Endometrial Hyperplasia, Grade 1 Endometrial Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Washington University School of MedicineUterine Preservation Via Lifestyle Transformation
Clinical Trial NCT05903131 is designed to study Treatment for Endometrial Hyperplasia, Grade 1 Endometrial Cancer. It is a Phase 2 interventional trial that is recruiting, having started on October 24, 2024, with plans to enroll 96 participants. Led by Washington University School of Medicine, it is expected to complete by October 31, 2029. The latest data from ClinicalTrials.gov was last updated on October 14, 2025.
Brief Summary
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.
Official Title
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
Conditions
Endometrial HyperplasiaGrade 1 Endometrial CancerOther Study IDs
NCT ID Number
Start Date (Actual)
2024-10-24
Last Update Posted
2025-10-14
Completion Date (Estimated)
2029-10-31
Enrollment (Estimated)
96
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
fertility-sparing
weight management
obesity
endometrial cancer
behavioral intervention
premenopausal endometrial hyperplasia
premenopausal endometrial cancer
weight management
obesity
endometrial cancer
behavioral intervention
premenopausal endometrial hyperplasia
premenopausal endometrial cancer
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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 |
Active ComparatorArm 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. | Enhanced Usual Care 1-3 page handouts Levonorgestrel-releasing IUD. Standard of care |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy | At 1 year |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
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 Medicine476 active trials to exploreNational Cancer Institute (NCI)3028 active trials to exploreStudy Central Contact
Contact: Andrea R Hagemann, M.D., MSCI, 314-362-1763, [email protected]
3 Study Locations in 1 Countries
Missouri
Washington University School of Medicine, St Louis, Missouri, 63110, United States
Andrea R Hagemann, M.D., MSCI, Contact, 314-362-1763, [email protected]
Andrea R Hagemann, M.D., MSCI, Principal Investigator
Graham Colditz, M.D., DrPH, Sub-Investigator
Ian Hagemann, M.D., Ph.D., Sub-Investigator
David Mutch, M.D., Sub-Investigator
Esther Lu, Ph.D., Sub-Investigator
Gary Patii, Ph.D., Sub-Investigator
David Morris, Ph.D., Sub-Investigator
Veronica Davé, Ph.D., Sub-Investigator
Recruiting
New Mexico
University of New Mexico, Albuquerque, New Mexico, 87106, United States
Carolyn Muller, M.D., Contact, 505-272-2111
Carolyn Muller, M.D., Principal Investigator
Kimberly Leslie, M.D., Sub-Investigator
Recruiting
Oklahoma
University of Oklahoma, Oklahoma City, Oklahoma, 73104, United States
Kathleen Moore, M.D., MS, Contact, 405-271-8707
Kathleen Moore, M.D., MS, Principal Investigator
Recruiting