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

Debulking Surgery for Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03956095
• Other study ID #: 19-108
• Status: Active, not recruiting
• Start date: May 16, 2019
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Debulking Surgery for Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Other:
• Daily Food Intake form
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (All Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
United States	Baptist Alliance MCI	Miami	Florida
United States	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (All Protocol Activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of patient participation		30 days after surgery

External Links

•   Memorial Sloan Kettering Cancer Center