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Behavioral Weight Loss + Progestin for Endometrial Hyperplasia

Phase 2

Recruiting

Led By Andrea R Hagemann, M.D., MSCI

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 2 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying if a weight loss strategy combined with progestin can help prevent/reverse endometrial cancer in premenopausal women wanting to preserve their fertility.

Who is the study for?

This trial is for premenopausal women aged 18-45 with obesity (BMI ≥ 30) and a diagnosis of complex atypical endometrial hyperplasia or grade 1 endometrial cancer, who want to preserve their uterus. They should be able to have an IUD placed, may already be on progestin therapy for less than six months, and must not have been in a weight loss trial recently or currently receiving chemotherapy/radiation.

What is being tested?

The study tests if combining a behavioral weight loss intervention via telemedicine with progestin treatment is more effective in preserving the uterus without atypia compared to just progestin treatment plus enhanced usual care. Participants will also receive either oral progestin or a levonorgestrel-releasing IUD.

What are the potential side effects?

Possible side effects include those related to progestin such as worsening insulin resistance, potential relapse of AEH or endometrial cancer, and general risks associated with intrauterine devices like discomfort or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (estimated to be 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of follow-up (estimated to be 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Atypia-free survival

Change in Cancer Worry Impact Events Scale (CWIES)

Endometrial cancer progression-free survival (EC-PFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss InterventionExperimental Treatment3 Interventions

* The levonorgestrel-releasing IUD is used in this study as per standard care. * The behavioral weight loss intervention consists of a telemedicine cognitive behavioral coaching program. At each session, patients will self-report weight, number of days they kept a food journal during the past week, average daily caloric intake for the week, number of days exercised for the week, total number of minutes of moderate physical activity, and average number of steps per day for the week.

Group II: Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual CareActive Control2 Interventions

* The levonorgestrel-releasing IUD is used in this study as per standard care. * Participants will be provided with 1- to 3-page handouts on topics including healthy eating, exercise, and behavioral eating strategies from materials provided on the American Cancer Society, Society of Gynecologic Oncology, and WebMD Nourish websites. These materials encourage weight loss through calorie counting, recording dietary intake, engaging in exercise programs, and using portion control strategies. * The participants randomized to this arm will cross over to the behavioral weight loss intervention arm at 12 months if they have not achieved resolution of AEH or grade 1 endometrial cancer.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Progestin

2015

Completed Phase 4

~10

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