A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia

202307204

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.

2024-06-30

2028-06-30

2029-06-30

Not yet recruiting

Early phase I

96

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 less than or equal to 6 months. * 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/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. * Prior or current receipt of metformin is allowed. * 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. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * Pregnant and/or breastfeeding. Participants must have a negative serum pregnancy test within 7 days of date of registration. * Contraindication to use of an IUD: * Congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity * PID, postpartum endometriosis, infected abortion in the last 3 months, acute cervicitis or vaginitis including bacterial vaginosis * Acute liver disease, liver tumor (benign or malignant) * Hypersensitivity to any component of the IUD (levonorgestrel, silicone, polyethylene) * Known or suspected carcinoma of the breast.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}

2024-05-14