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Clinical Trials/NCT03956095
NCT03956095
Completed
Not Applicable

Preoperative Nutrition Intervention for Patients Undergoing Primary Surgical Debulking of Ovarian Cancer: A Feasibility Study

Memorial Sloan Kettering Cancer Center8 sites in 1 country23 target enrollmentMay 16, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Debulking Surgery for Ovarian Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
23
Locations
8
Primary Endpoint
rate of patient participation
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

The purpose of this study is to find out if it is possible to establish a nutritional support program for people who are scheduled to receive primary debulking surgery.

Design: This will be a prospective observational study to assess the feasibility of implementing a preoperative nutrition supplementation program.

Registry
clinicaltrials.gov
Start Date
May 16, 2019
End Date
December 19, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Scheduled to undergo primary surgical debulking of ovarian, fallopian tube and primary peritoneal cancer
  • Have a sufficient preoperative window during which the intervention can occur, with the last day of supplementation at least one and no more than two days prior to surgery; scheduling of the procedure should not be delayed due to participation in this investigation

Exclusion Criteria

  • Have received neoadjuvant chemotherapy
  • Debulking surgery scheduled less than 8 days from initial visit
  • Are scheduled for a minimally invasive procedure
  • Unable to tolerate oral intake or have gastrointestinal issues that would prevent or prohibit oral supplement consumption
  • Have diabetes mellitus
  • Have allergies to the Ensure Surgery Immunonutrition Shake supplement
  • Have galactosemia

Outcomes

Primary Outcomes

rate of patient participation

Time Frame: 30 days after surgery

Study Sites (8)

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