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



Status:Recruiting
Conditions:Cervical Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/10/2018
Start Date:July 2015
Contact:Emily Ko, MD
Email:PennCancerTrials@emergingmed.com
Phone:855-216-0098

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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.


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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Emily Ko, MD
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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from
Philadelphia, PA
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