Uterine Preservation Via Lifestyle Transformation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWashington University School of Medicine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Telemedicine behavioral weight intervention
BehavioralWeekly 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
DrugReleased via the levonorgestrel-releasing IUD.
Enhanced usual care
Behavioral1-3 page handouts
Levonorgestrel-releasing IUD.
DrugStandard of care
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss InterventionExperimental treatment 3 interventions
Group B: Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual CareActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy
Time frame
At 1 yearSecondary outcomes
1
Time to resolution of atypical endometrial hyperplasia (AEH)
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
Time frame
Through completion of follow-up (estimated to be 2 years)2
Time to resolution of endometrial cancer
Time frame
Through completion of follow-up (estimated to be 2 years)3
Atypia-free survival
-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.
Time frame
Through completion of follow-up (estimated to be 2 years)4
Endometrial cancer progression-free survival (EC-PFS)
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.
Time frame
Through completion of follow-up (estimated to be 2 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov