Endometrial Hyperplasia, Grade 1 Endometrial Cancer
Conditions
Keywords
fertility-sparing, weight management, obesity, endometrial cancer, behavioral intervention, premenopausal endometrial hyperplasia, premenopausal endometrial cancer
Brief 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.
Interventions
BEHAVIORALTelemedicine behavioral weight intervention
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.
DRUGProgestin
Released via the levonorgestrel-releasing IUD.
BEHAVIORALEnhanced usual care
1-3 page handouts
DRUGLevonorgestrel-releasing IUD.
Standard of care
Sponsors
Washington University School of Medicine
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy | At 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to resolution of atypical endometrial hyperplasia (AEH) | 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 |
| Time to resolution of endometrial cancer | Through completion of follow-up (estimated to be 2 years) | — |
| Atypia-free survival | 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. |
| Endometrial cancer progression-free survival (EC-PFS) | 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. |
| Change in weight | Through completion of follow-up (estimated to be 2 years) | — |
| Change in Cancer Worry Impact Events Scale (CWIES) | 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. |
Countries
United States
Contacts
CONTACTAndrea R Hagemann, M.D., MSCI
PRINCIPAL_INVESTIGATORAndrea R Hagemann, M.D., MSCI
Washington University School of Medicine
Outcome results
None listed