Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
8 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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