Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Weight Loss

Obesity

Body Weight

Hyperplasia

Endometrial Hyperplasia

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Patients are referred to a weight loss specialist for assistance with weight loss and medical chart reviews are performed at baseline and every 3 months for 24 months. Patients complete Quality-of-Life Assessment (EORTC- QLQ-C30 and EORTC-QLQ-EN24) at baseline, 12, and 24 months. Patients are also contacted at 90 days to determine whether they have initiated any weight loss interventions.

Weight Loss Specialist

Quality-of-Life Assessment

Medical Chart Review

Amelia Jernigan

This pilot clinical trial studies whether obese stage I-II endometrial cancer survivors or patients with atypical hyperplasia (abnormal cells in the lining of the uterus) would go see a weight loss specialist if it was recommended by their cancer doctor. Excess body weight or obesity is one of the most common contributors to (causes of) endometrial cancer. Over two-thirds of women who have survived endometrial cancer are obese. Complications of obesity, such as heart disease are often more dangerous than the cancer itself. A weight loss of even 5-10% of excess body weight is associated with improved health. Often, meeting with a doctor or person who is an expert in weight loss (bariatric specialist) is the best way to lose weight and keep it off. Endometrial cancer survivors or patients with atypical hyperplasia who go see a weight loss specialist recommended by their doctor may be able to achieve a healthier body weight.

PRIMARY OBJECTIVES:

I.Our primary outcome for the purposes of the pilot study will be to describe recruitment in terms of accrual (number of subjects who agree to participate) and compliance (number of patients who follow up with the obesity referral). This will be described in terms of a specific number as well as a rate.

* Accrual rate is the number of women accrued divided by the number of women approached for the study.
* Compliance rate is the number of women who comply with the referral divided by the number of women accrued.

Several secondary outcomes will be described:

* Weight loss at 12 \& 24 months.
* Obesity interventions implemented (medical, surgical, behavioral, and selfguided)
* The incidence of obesity related comorbidities at baseline and 12 and 24 months (myocardial infarction, venous thromboembolism, stroke, diabetes and hypertension.)
* Cancer specific outcomes (recurrence rate, progression free survival).
* Mortality otucomes (Overall survival, cause of death)
* In patients with diabetes, we will record the number of diabetic medications required and the most recent hemoglobin A1C.
* In patients with hypertension, we will record the number of antihypertensive medications required
* We will assess the level of functioning, quality of life and symptomatology of women at baseline, 12 and 24 months using the EORTC-QLQ-C30 and EORTC-QLQ-EN24.

  * Primary and secondary outcomes will be compared in relation to the timing of the referral by the gynecologic oncologist (within 1 year or greater than 1 year out from the endometrial cancer/hyperplasia diagnosis).
  * Secondary outcomes of subjects included in this study will be compared to a historic cohort matches for age, stage and BMI in a 2:1 fashion.

OUTLINE:

Patients are referred to a weight loss specialist for assistance with weight loss and chart reviews are performed at baseline and every 3 months for 24 months. Patients complete the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)-Cancer (C)30 and EORTC-QLQ-Endometrial Cancer (EN)24 at baseline, 12, and 24 months. Patients are also contacted at 90 days to determine whether they have initiated any weight loss interventions.

Weight Loss Referral for Healthier Survivorship in Obese Stage I-II Endometrial Cancer Survivors or Atypical Hyperplasia

Referral of Obese Endometrial Cancer Survivors to a Bariatric Specialist and a Healthier Survivorship: A Prospective Intervention Cohort Study

Descriptive statistics will be used. Will be compared using chi square or fisher exact tests.

Descriptive statistics will be used. Will compare groups using a paired t-test.

Will be compared using chi square or fisher exact tests.

Descriptive statistics will be used to detail incidence of new major health events (myocardial infarction, stroke, new diabetes diagnosis, new venous thromboembolism, new hypertension diagnosis, death, date of death, cause of death). The occurrence new major health events and cancer related events will be compared using chi square or fisher exact tests.

Descriptive statistics will be used. Will be described with Kaplan Meier curves.

Descriptive statistics will be used to detail cancer related outcomes (cancer recurrence, date and location of recurrence, cancer related death).

Will compare groups using a paired t-test.

National Cancer Institute (NCI)

Case Comprehensive Cancer Center

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Carcinoma

Carcinoma, Endometrioid

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Neoplasms

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Ovarian Cancer

Hypoglycemic Agents

All Drugs and Chemicals

Reproductive Control Agents

Metformin

Levonorgestrel

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

Contraceptives, Oral

Metformin tablets, 500mg twice daily orally, 6 months Levonorgestrel (Mirena®) 52mg Intrauterine drug delivery system, 6 months

Levonorgestrel (Mirena®) 52mg Intrauterine drug delivery system, 6 months

Levonorgestrel (Mirena®) 52mg Intrauterine drug delivery system, 6 months Weight Loss Intervention will be delivered via Weight Watchers

Andreas Obermair

Currently the standard treatment for early stage endometrial cancer or endometrial hyperplasia with atypia is a total hysterectomy (an operation to remove the uterus) and removal of both ovaries. While highly effective, this surgery carries significant side effects for:

* young women who still wish to have children and would lose fertility; and
* women with one or more disorders (or diseases) in addition to the early stage endometrial cancer or endometrial hyperplasia with atypia and/or morbid obesity who are at risk for surgical complications making surgery unsafe.

This study will access a new approach to the treatment of endometrial cancer to spare women of having to undergo major surgery that may be unwanted or unnecessary.

Mirena is approved in Australia for contraception, to treat heavy bleeding, and to prevent thickening of the lining of the uterus (endometrial hyperplasia) during oestrogen replacement therapy (HRT). However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. This research project will test to see if Mirena is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia.

Metformin is approved in Australia to treat Diabetes. However it is not approved to treat early stage endometrial cancer or endometrial hyperplasia with atypia. Therefore, it is an experimental treatment for early stage endometrial cancer and endometrial hyperplasia with atypia. This means that it must be tested to see if it is an effective treatment for early stage endometrial cancer and endometrial hyperplasia with atypia.

Weight loss interventions are feasible and safe, and already being implemented by gynaecologic oncologist to make women eligible for surgery. Weight loss of 7% body weight induces a large biological effect (for example reduces incidence of diabetes by 58%, and hypertension by 26%).

Improving the Treatment for Women With Early Stage Cancer of the Uterus

A Phase II Randomised Clinical Trial of Mirena® ± Metformin ± Weight Loss Intervention in Patients With Early Stage Cancer of the Endometrium

To predict the response to treatment through blood and tissue molecular biomarkers and to increase our molecular understanding of the biological pathogenesis of "early" EAC.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Weight Loss Referral for Healthier Survivorship in Obese Stage I-II Endometrial Cancer Survivors or Atypical Hyperplasia	NCT02342730	Complex Endomet... Stage IA Uterin... Stage IB Uterin... Stage II Uterin...	Weight Loss Spe... Quality-of-Life... Medical Chart R...	18 Years - 65 Years	Case Comprehensive Cancer Center
Improving the Treatment for Women With Early Stage Cancer of the Uterus	NCT01686126	Complex Endomet... Grade 1 Endomet...	Levonorgestrel Metformin	18 Years -	Queensland Centre for Gynaecological Cancer
Weight Loss Referral for Healthier Survivorship in Obese Stage I-II Endometrial Cancer Survivors or Atypical Hyperplasia	NCT02342730	Complex Endomet... Stage IA Uterin... Stage IB Uterin... Stage II Uterin...	Weight Loss Spe... Quality-of-Life... Medical Chart R...	18 Years - 65 Years	Case Comprehensive Cancer Center

Spots Global Cancer Trial Database for complex endometrial hyperplasia with atypia