Uterine Preservation Via Lifestyle Transformation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-24

Study Completion Date

2029-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometrial Hyperplasia Grade 1 Endometrial Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss Intervention

* 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 Type EXPERIMENTAL

Telemedicine behavioral weight intervention

Intervention Type BEHAVIORAL

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.

Progestin

Intervention Type DRUG

Released via the levonorgestrel-releasing IUD.

Levonorgestrel-releasing IUD.

Intervention Type DRUG

Standard of care

Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual Care

* 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.

Group Type ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type BEHAVIORAL

1-3 page handouts

Levonorgestrel-releasing IUD.

Intervention Type DRUG

Standard of care

Interventions

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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.

Intervention Type BEHAVIORAL

Progestin

Released via the levonorgestrel-releasing IUD.

Intervention Type DRUG

Enhanced usual care

1-3 page handouts

Intervention Type BEHAVIORAL

Levonorgestrel-releasing IUD.

Standard of care

Intervention Type DRUG

Eligibility Criteria

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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.
* Undergoing uterine-sparing management (e.g. due to interest in fertility preservation, interest in uterine preservation, provider recommendation, or other reason).
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No