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

NCT ID: NCT03956095

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-16

Study Completion Date

2025-12-19

Brief Summary

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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

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Conditions

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Debulking Surgery for Ovarian Cancer

Keywords

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Nutritional Supplement Shakes 19-108

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type DIETARY_SUPPLEMENT

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

Daily Food Intake form

Intervention Type 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.

Interventions

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Ensure Surgery Immunonutrition Shake supplements

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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vance Broach, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Baptist Alliance MCI

Miami, Florida, United States

Site Status

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Site Status

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Site Status

Memorial Sloan Kettering Commack (All Protocol Activities)

Commack, New York, United States

Site Status

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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19-108

Identifier Type: -

Identifier Source: org_study_id