Trial Title:
A Behavioral Intervention to Promote Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia
NCT ID:
NCT05903131
Condition:
Endometrial Hyperplasia
Grade 1 Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Endometrial Hyperplasia
Obesity
Hyperplasia
Levonorgestrel
Progestins
Conditions: Keywords:
fertility-sparing
weight management
obesity
endometrial cancer
behavioral intervention
premenopausal endometrial hyperplasia
premenopausal endometrial cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Telemedicine behavioral weight intervention
Description:
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.
Arm group label:
Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss Intervention
Intervention type:
Drug
Intervention name:
Progestin
Description:
Released via the levonorgestrel-releasing IUD.
Arm group label:
Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss Intervention
Intervention type:
Behavioral
Intervention name:
Enhanced usual care
Description:
1-3 page handouts
Arm group label:
Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual Care
Intervention type:
Drug
Intervention name:
Levonorgestrel-releasing IUD.
Description:
Standard of care
Arm group label:
Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss Intervention
Arm group label:
Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual Care
Summary:
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.
Criteria for 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.
- Interested in uterine preservation and/or fertility-sparing treatment.
- 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrea R Hagemann, M.D., MSCI
Phone:
314-362-1763
Email:
hagemanna@wustl.edu
Investigator:
Last name:
Andrea R Hagemann, M.D., MSCI
Email:
Principal Investigator
Investigator:
Last name:
Graham Colditz, M.D., DrPH
Email:
Sub-Investigator
Investigator:
Last name:
Ian Hagemann, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
David Mutch, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Esther Lu, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Gary Patii, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
David Morris, Ph.D.
Email:
Sub-Investigator
Facility:
Name:
University of New Mexico
Address:
City:
Albuquerque
Zip:
87106
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Carolyn Muller, M.D.
Phone:
505-272-2111
Investigator:
Last name:
Carolyn Muller, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Kimberly Leslie, M.D.
Email:
Sub-Investigator
Facility:
Name:
University of Oklahoma
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Kathleen Moore, M.D., MS
Phone:
405-271-8707
Investigator:
Last name:
Kathleen Moore, M.D., MS
Email:
Principal Investigator
Start date:
October 31, 2024
Completion date:
October 31, 2029
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05903131
http://www.siteman.wustl.edu
