Clinical trial NCT05903131: A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia
Official title: A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Endometrial Hyperplasia
Grade 1 Endometrial Cancer
Keywords: fertility-sparing
weight management
obesity
endometrial cancer
behavioral intervention
premenopausal endometrial hyperplasia
premenopausal endometrial cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-06-15
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.
* 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.

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.

Primary outcomes:
measure: Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy
timeFrame: At 1 year
Secondary outcomes:
measure: Time to resolution of atypical endometrial hyperplasia (AEH)
timeFrame: Through completion of follow-up (estimated to be 2 years)
measure: Time to resolution of endometrial cancer
timeFrame: Through completion of follow-up (estimated to be 2 years)
measure: Atypia-free survival
timeFrame: Through completion of follow-up (estimated to be 2 years)
measure: Endometrial cancer progression-free survival (EC-PFS)
timeFrame: Through completion of follow-up (estimated to be 2 years)
measure: Change in weight
timeFrame: Through completion of follow-up (estimated to be 2 years)
measure: Change in Cancer Worry Impact Events Scale (CWIES)
timeFrame: At enrollment, 6 months, 12 months, end of intervention, and 24 months (estimated to be 2 years)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
Study officials:
affiliation: Washington University School of Medicine
name: Andrea R Hagemann, M.D., MSCI
role: PRINCIPAL_INVESTIGATOR
References: