Study of Nutritional Supplement Shakes in People About to Receive Their Debulking Surgery for Ovarian Cancer
Preoperative Nutrition Intervention for Patients Undergoing Primary Surgical Debulking of Ovarian Cancer: A Feasibility Study
1 other identifier
observational
23
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2019
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2019
CompletedFirst Submitted
Initial submission to the registry
May 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2025
CompletedDecember 30, 2025
December 1, 2025
6.6 years
May 17, 2019
December 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of patient participation
30 days after surgery
Study Arms (1)
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.
Interventions
Three Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure.
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.
Eligibility Criteria
Eligible patients will include those who present to MSK for primary surgical management of ovarian cancer.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Baptist Alliance MCI
Miami, Florida, 33143, United States
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
Biospecimen
Blood
Study Officials
- PRINCIPAL INVESTIGATOR
Vance Broach, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2019
First Posted
May 20, 2019
Study Start
May 16, 2019
Primary Completion
December 19, 2025
Study Completion
December 19, 2025
Last Updated
December 30, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.