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

Active, not recruiting

• Conditions: Debulking Surgery for Ovarian Cancer
• Interventions: Dietary Supplement: Ensure Surgery Immunonutrition Shake supplements; Other: Daily Food Intake form

• Registration Number: NCT03956095
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-05-16
• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ensure Surgery Immunonutrition Shake supplements	Ensure Surgery Immunonutrition Shake supplements	Participants will be provided with and instructed to drink three Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure.
Ensure Surgery Immunonutrition Shake supplements	Daily Food Intake form	Participants will be provided with and instructed to drink three Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure.

Primary Outcome Measures

Name	Time	Method
rate of patient participation	30 days after surgery

Trial Locations

Locations (8)

Baptist Alliance MCI; 🇺🇸 Miami, Florida, United States

Memorial Sloan Kettering Bergen (All Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, 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

Memorial Sloan Kettering Nassau (All Protocol Activities); 🇺🇸 Uniondale, New York, United States