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

Endometrial Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05903131
• Other study ID #: 202307204
• Secondary ID: P50CA265793
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 30, 2024
• Est. completion date: June 30, 2029

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: Andrea R Hagemann, M.D., MSCI
• Phone: 314-362-1763
• Email: hagemanna[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Endometrial Neoplasms
• Hyperplasia
• Obesity

Intervention

Behavioral:
• 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.

Drug:
• Progestin
Released via the levonorgestrel-releasing IUD.

Behavioral:
• Enhanced usual care
1-3 page handouts

Drug:
• Levonorgestrel-releasing IUD.
Standard of care

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy		At 1 year
Secondary	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)
Secondary	Time to resolution of endometrial cancer		Through completion of follow-up (estimated to be 2 years)
Secondary	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)
Secondary	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)
Secondary	Change in weight		Through completion of follow-up (estimated to be 2 years)
Secondary	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)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine