Back to resultsEvaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer
Primary Purpose
Obese, Endometrial Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perioperative Caloric Restriction Program
Sponsored by
About this trial
This is an interventional other trial for Obese focused on measuring newly diagnosed patients
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
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Calorie Restricted (CR) program
Arm Description
The intervention will provide individualized CR program, meal replacement products and nutritional counseling sessions.
Outcomes
Primary Outcome Measures
Number of completed perioperative caloric restriction program in obese newly diagnosed endometrial cancer patients
Secondary Outcome Measures
Full Information
NCT ID
NCT02665962
First Posted
January 15, 2016
Last Updated
March 9, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02665962
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
July 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Endometrial Cancer
Keywords
newly diagnosed patients
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calorie Restricted (CR) program
Arm Type
Other
Arm Description
The intervention will provide individualized CR program, meal replacement products and nutritional counseling sessions.
Intervention Type
Other
Intervention Name(s)
Perioperative Caloric Restriction Program
Primary Outcome Measure Information:
Title
Number of completed perioperative caloric restriction program in obese newly diagnosed endometrial cancer patients
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nawar Abdul Latif, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer
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