Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer

Stopped early · Not applicable

Conditions studied: Obese, Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT02665962

Run by

Abramson Cancer Center at Penn Medicine

People needed

8

Starts

2015-07-01

Expected to finish

2018-07-01

Last updated by the study team

2020-03-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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