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NCT Number: NCT05903131

Uterine Preservation Via Lifestyle Transformation

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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Key information

Conditions

Endometrial Hyperplasia Body Weight Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Grade 1 Endometrial Cancer Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine, St Louis, Missouri, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine behavioral weight intervention

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

Drug

Released via the levonorgestrel-releasing IUD.

Enhanced Usual Care

Behavioral

1-3 page handouts

Levonorgestrel-releasing IUD.

Drug

Standard of care

Primary outcomes

  1. Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy

    Time frame: At 1 year

Secondary outcomes

  1. Time to resolution of atypical endometrial hyperplasia (AEH)

    Time frame: Through completion of follow-up (estimated to be 2 years)

    Defined as the period of time in months/days from the first biopsy to show AEH or grade 1 endometrial cancer to the first biopsy that shows no evidence of hyperplasia or malignancy

  2. Time to resolution of endometrial cancer

    Time frame: Through completion of follow-up (estimated to be 2 years)

  3. Atypia-free survival

    Time frame: Through completion of follow-up (estimated to be 2 years)

    -Defined as the time interval from the date of positive treatment response (as determined by biopsy) to the date of atypical endometrial hyperplasia (AEH) recurrence. AEH-free or the patients with lost to follow-up will be censored at the last follow-up.

  4. Endometrial cancer progression-free survival (EC-PFS)

    Time frame: Through completion of follow-up (estimated to be 2 years)

    EC-PFS is defined as the time interval from the date of positive treatment response (as determined by biopsy) to the date of recurrence of EC. Endometrial cancer-free patients or the patients with lost to follow-up will be censored at the last follow-up.

  5. Change in weight

    Time frame: Through completion of follow-up (estimated to be 2 years)

  6. Change in Cancer Worry Impact Events Scale (CWIES)

    Time frame: At enrollment, 6 months, 12 months, end of intervention, and 24 months (estimated to be 2 years)

    The CWIES is a 15-item self-report measure evaluating stress reactions and traumatic experiences, specifically inquiring about cancer worry-specific distress. Range of values for each individual item will be a Likert Scale from 0-5. 0=not at all and 5=often. The higher the score, the more cancer-worry specific distress the participant has.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea R Hagemann, M.D., MSCI

CONTACT

[email protected]

314-362-1763

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jun 15, 2023
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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