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OpenTrials
Completed

NCT Number: NCT03956095

Study of Nutritional Supplement Shakes in People About to Receive Their Debulking Surgery for Ovarian Cancer

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.

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Key information

Conditions

Debulking Surgery for Ovarian Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Baptist Alliance MCI, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • 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

Treatment and study plan

Ensure Surgery Immunonutrition Shake supplements

Dietary Supplement

Three Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure.

Daily Food Intake form

Other

On the day of surgery, the patient will return her Daily Supplement/Food Intake Forms and complete the Day of Surgery Intake Form can also be completed the day before surgery and the Daily Supplement/Food Intake Forms can be returned at the patient's postoperative appointment.

Primary outcomes

  1. rate of patient participation

    Time frame: 30 days after surgery

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 20, 2019
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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