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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA265793 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Levonorgestrel-releasing IUD (LNG-IUD) + Behavioral Weight Loss Intervention | Experimental |
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| Arm 2: Levonorgestrel-releasing IUD (LNG-IUD) + Enhanced Usual Care | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with atypical endometrial hyperplasia (AEH)-free biopsy | At 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through completion of follow-up (estimated to be 2 years) |
| Time to resolution of endometrial cancer |
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Inclusion Criteria:
Diagnosis of histologically confirmed complex atypical endometrial hyperplasia (AEH) or grade 1 endometrial cancer.
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea R Hagemann, M.D., MSCI | Contact | 314-362-1763 | hagemanna@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrea R Hagemann, M.D., MSCI | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D004714 | Endometrial Hyperplasia |
| D009765 | Obesity |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D011372 | Progestins |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Progestin | Drug | Released via the levonorgestrel-releasing IUD. |
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| Enhanced usual care | Behavioral | 1-3 page handouts |
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| Levonorgestrel-releasing IUD. | Drug | Standard of care |
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| Through completion of follow-up (estimated to be 2 years) |
| 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. | Through completion of follow-up (estimated to be 2 years) |
| 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. | Through completion of follow-up (estimated to be 2 years) |
| Change in weight | Through completion of follow-up (estimated to be 2 years) |
| Change in Cancer Worry Impact Events Scale (CWIES) | 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. | At enrollment, 6 months, 12 months, end of intervention, and 24 months (estimated to be 2 years) |
| University of New Mexico | Recruiting | Albuquerque | New Mexico | 87106 | United States |
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| University of Oklahoma | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D020164 | Chemical Actions and Uses |