Brief Title
Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer
Official Title
Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer
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.
Study Type
Interventional
Primary Outcome
Number of completed perioperative caloric restriction program in obese newly diagnosed endometrial cancer patients
Condition
Obese
Intervention
Perioperative Caloric Restriction Program
Study Arms / Comparison Groups
Calorie Restricted (CR) program
Description: The intervention will provide individualized CR program, meal replacement products and nutritional counseling sessions.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
8
Start Date
July 2015
Completion Date
July 2018
Primary Completion Date
July 2018
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nawar Abdul Latif, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02665962
Organization ID
UPCC 09815
Responsible Party
Sponsor
Study Sponsor
Abramson Cancer Center of the University of Pennsylvania
Study Sponsor
Nawar Abdul Latif, MD, Principal Investigator, Abramson Cancer Center of the University of Pennsylvania
Verification Date
March 2020