Actively Recruiting
Uterine Preservation Via Lifestyle Transformation
Led by Washington University School of Medicine · Updated on 2026-01-20
96
Participants Needed
3
Research Sites
261 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Uterine Preservation Via Lifestyle Transformation
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
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.
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ECOG performance status of 0-2.
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At least 18 years of age and no more than 45 years of age.
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Undergoing uterine-sparing management (e.g. due to interest in fertility preservation, interest in uterine preservation, provider recommendation, or other reason).
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BMI ≥ 30 kg/m^2.
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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.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
2
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
3
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
A
Andrea R Hagemann, M.D., MSCI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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