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

Not Applicable

Terminated

• Conditions: Endometrial Cancer; Obese
• Interventions: Other: Perioperative Caloric Restriction Program

• Registration Number: NCT02665962
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-28
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Calorie Restricted (CR) program	Perioperative Caloric Restriction Program	The intervention will provide individualized CR program, meal replacement products and nutritional counseling sessions.

Primary Outcome Measures

Name	Time	Method
Number of completed perioperative caloric restriction program in obese newly diagnosed endometrial cancer patients	2 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States