RecruitingPhase 2NCT05903131

Uterine Preservation Via Lifestyle Transformation

UPLifT-Endo: Uterine Preservation Via Lifestyle Transformation A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Atypical Endometrial Hyperplasia or Grade 1 Endometrial Cancer


Sponsor

Washington University School of Medicine

Enrollment

96 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether intensive lifestyle changes — including dietary modification and exercise — can improve the response to hormonal treatment (progestin therapy) in premenopausal women with early-stage endometrial cancer or complex atypical endometrial hyperplasia (a pre-cancer condition of the uterine lining) who want to preserve their uterus and fertility. **You may be eligible if...** - You have been diagnosed with complex atypical endometrial hyperplasia or Grade 1 endometrial cancer (early, low-risk) - You are premenopausal and still have your uterus - You are between 18 and 45 years old - Your BMI is 30 or above (overweight or obese) - You are choosing uterine-sparing management (avoiding hysterectomy) - You are willing to have a hormonal IUD placed at study entry **You may NOT be eligible if...** - You have high-grade or advanced endometrial cancer - You are postmenopausal - You are unable or unwilling to follow the lifestyle intervention Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALTelemedicine 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.

DRUGProgestin

Released via the levonorgestrel-releasing IUD.

BEHAVIORALEnhanced usual care

1-3 page handouts

DRUGLevonorgestrel-releasing IUD.

Standard of care


Locations(3)

Washington University School of Medicine

St Louis, Missouri, United States

University of New Mexico

Albuquerque, New Mexico, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05903131


Related Trials