Study on Using GLP-1 Agonist with Levonorgestrel IUD for Obese Patients with Early-Stage Endometrial Cancer

Sponsor: University of Florida

Sponsor score: 60

ClinicalTrials ID:NCT07107334

Provider View

This clinical trial is exploring a new treatment approach for obese patients with early-stage endometrial cancer who are not suitable for surgery or wish to preserve fertility. The study combines a GLP-1 agonist, a medication that helps with weight loss and blood sugar control, with a levonorgestrel intrauterine device (IUD).

Patient Parameters

Program Overview

The study aims to test the effectiveness of combining a GLP-1 agonist, a type of medication that helps lower blood sugar and aids in weight loss, with a levonorgestrel IUD in patients who have early-stage endometrial cancer and are either not good candidates for surgery or want to preserve their fertility. GLP-1 agonists, like liraglutide and semaglutide, are known for their weight loss benefits and may also reduce the risk of certain obesity-related cancers, including endometrial cancer. This study will help determine their role in preventing and treating this type of cancer.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Diagnosed with early-stage endometrial cancer or endometrial intraepithelial neoplasia within the last 3 months.
  • Diagnosis confirmed by in-house pathology review if done outside the study site.
  • ECOG performance status between 0 and 3, indicating varying levels of activity.
  • No cancer spread outside the uterus or into the uterine muscle, confirmed by MRI or ultrasound within the last 3 months.
  • Body Mass Index (BMI) of 30 or higher, with either multiple health issues or a desire to maintain fertility.
  • Up-to-date breast exams and imaging as per age recommendations.
  • Willingness to provide written consent and follow study procedures.

Exclusion Criteria

  • Diagnosed with more advanced or different types of endometrial cancer.
  • Tumors that do not have estrogen receptors.
  • Signs of cancer spread or confirmed metastatic disease.
  • Abnormal cervical cell results.
  • Diagnosed with thyroid cancer, pancreatitis, or certain genetic conditions.
  • Pregnant or breastfeeding women.
  • History of a specific type of thyroid cancer.
  • IUD placed more than 14 days before joining the study.
  • More than one active cancer at the time of joining the study, unless approved by the study doctor.
  • Any other health condition that could interfere with the study or increase risk, as judged by the doctor.
  • Individuals who are incarcerated or detained for treatment of mental or physical illness.

Locations

FACILITYZIPCITYSTATE
University of Florida32608GainesvilleFlorida

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