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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02665962
• Other study ID #: UPCC 09815
• Status: Terminated
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 2018

Study information

• Verified date: March 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Obese

Intervention

Other:
• Perioperative Caloric Restriction Program

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of completed perioperative caloric restriction program in obese newly diagnosed endometrial cancer patients		2 years