RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding a weight-loss program to progestin hormone treatment helps women keep their uterus free of abnormal cells after one year. It compares this program with progestin plus enhanced usual care. It is for women ages 18–45 with obesity who have not reached menopause and have certain abnormal cells or grade 1 cancer in the lining of the uterus.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have complex atypical endometrial hyperplasia (AEH), which means abnormal cells in the uterus lining, or grade 1 cancer in that lining, confirmed by a tissue test.
  • Have a uterus and not yet have reached menopause.
  • Be 18–45 years old.
  • Be able to care for yourself and be out of bed or a chair for more than half the day, even if you cannot work.
  • Be getting treatment that keeps the uterus in place.
  • Have a body mass index (BMI) of 30 or higher, a measure of obesity based on height and weight.
  • Be willing to have a progestin-releasing IUD placed in the uterus when joining. Past or current progestin treatment is allowed.
  • Be able to understand the study and willing to sign a written consent form.

Who can't join

  • Currently be receiving chemotherapy or radiation to treat any cancer.
  • Be pregnant or breastfeeding. A negative pregnancy test is needed during screening and within 7 days before IUD placement; if an IUD is already in place, the study assumes no pregnancy.
  • Have an active infection in the pelvic area when the IUD is placed, or another reason your doctor says an IUD is not safe for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (3)

MO

  • Washington University School of Medicine · St Louis, MO 63110Andrea R Hagemann, M.D., MSCI · Study contact · 314-362-1763 · hagemanna@wustl.eduAndrea R Hagemann, M.D., MSCI · Principal investigatorGraham Colditz, M.D., DrPH · Sub-investigatorIan Hagemann, M.D., Ph.D. · Sub-investigatorMore trials in St Louis

NM

  • University of New Mexico · Albuquerque, NM 87106Carolyn Muller, M.D. · Study contact · 505-272-2111Carolyn Muller, M.D. · Principal investigatorKimberly Leslie, M.D. · Sub-investigatorMore trials in Albuquerque

OK