Behavioral intervention for weight management in premenopausal women with obesity and endometrial hyperplasia
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
PHASE2 · Washington University School of Medicine · NCT05903131
This study is testing a weight management program using telemedicine to help premenopausal women with obesity and endometrial hyperplasia improve their health and reduce the need for surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Washington University School of Medicine (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (St Louis, Missouri and 2 other locations) |
| Trial ID | NCT05903131 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a behavioral intervention designed to promote primary prevention and uterine preservation in premenopausal women diagnosed with atypical endometrial hyperplasia or grade 1 endometrial cancer. The study will utilize telemedicine to provide weight management support alongside progestin therapy and enhanced usual care. By addressing obesity, which is a significant risk factor for endometrial cancer, the trial seeks to improve treatment outcomes and reduce the need for hysterectomy. Participants will be monitored for their response to the intervention and the effectiveness of fertility-sparing treatments.
Who should consider this trial
Good fit: Ideal candidates include premenopausal women aged 18 to 45 with a diagnosis of atypical endometrial hyperplasia or grade 1 endometrial cancer who have a BMI of 30 kg/m² or higher.
Not a fit: Patients who are postmenopausal or have a BMI below 30 kg/m² may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help women manage their weight and preserve their fertility while effectively treating endometrial hyperplasia and preventing progression to cancer.
How similar studies have performed: Other studies have shown promise in using behavioral interventions for weight management in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Undergoing uterine-sparing management (e.g. due to interest in fertility preservation, interest in uterine preservation, provider recommendation, or other reason). * 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. Exclusion Criteria: * 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.
Where this trial is running
St Louis, Missouri and 2 other locations
- Washington University School of Medicine — St Louis, Missouri, United States (RECRUITING)
- University of New Mexico — Albuquerque, New Mexico, United States (RECRUITING)
- University of Oklahoma — Oklahoma City, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Andrea R Hagemann, M.D., MSCI — Washington University School of Medicine
- Study coordinator: Andrea R Hagemann, M.D., MSCI
- Email: hagemanna@wustl.edu
- Phone: 314-362-1763
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometrial Hyperplasia, Grade 1 Endometrial Cancer, fertility-sparing, weight management, obesity, endometrial cancer, behavioral intervention, premenopausal endometrial hyperplasia