Endometrial Cancer, Obese
Conditions
Keywords
newly diagnosed patients
Brief summary
80% of endometrial cancer patients are overweight or obese. Preclinical and clinical data have shown that caloric restriction (CR) protects against organ injury and decreases perioperative morbidity. This is a feasibility trial to evaluate the effect of a 6 week perioperative CR on surgical and patient-reported outcomes in 20 obese newly diagnosed endometrial cancer patients. The intervention will provide individualized CR program, meal replacement products and nutritional counselling sessions.
Interventions
OTHERPerioperative Caloric Restriction Program
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed with Endometrial Cancer * BMI30 kg/m2 * 18 year of age or older * Scheduled for definitive surgical intervention (hysterectomy, bilateral salpingoopherectomy with or without lymphadenectomy) in the following 2-3 weeks as part of the standard of care * Have ECOG performance status of 0-1 * Have a life expectancy of at least 1 year
Exclusion criteria
* Inability to communicate in English * BMI30 kg/m2 * Age18 * Have any uncontrolled serious medical or psychiatric conditions that would affect their ability to participate in an intervention study, (e.g., severe/uncontrolled diabetes mellitus, severe cardiac and/or pulmonary disease and/or depression) * Diagnosed with any other invasive malignancy currently, in the last five years or expected to undergo active treatment with either cytotoxic chemotherapy or radiation during the 6 week caloric restriction period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of completed perioperative caloric restriction program in obese newly diagnosed endometrial cancer patients | 2 years |
Countries
United States
Outcome results
None listed