Debulking Surgery for Ovarian CancerNCT03956095
Study of Nutritional Supplement Shakes in People About to Receive Their Debulking Surgery for Ovarian Cancer
An observational study of Debulking Surgery for Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Debulking Surgery for Ovarian Cancer
- What is being tested?
- Ensure Surgery Immunonutrition Shake supplements and Daily Food Intake form
- How many people
- 23 participants
- Where
- 8 sitesUnited States
- Study dates
- 16 May 2019to 19 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will include those who present to MSK for primary surgical management of ovarian cancer.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Baptist Alliance MCI
Miami, Florida, 33143
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: Preoperative Nutrition Intervention for Patients Undergoing Primary Surgical Debulking of Ovarian Cancer: A Feasibility Study
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.
- Conditions
- Debulking Surgery for Ovarian Cancer
- Being tested
- Ensure Surgery Immunonutrition Shake supplements, Daily Food Intake form
- Keywords
- Nutritional Supplement Shakes, 19-108
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure Surgery Immunonutrition Shake supplementsDietary supplement
Three Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure.
Daily Food Intake formOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Ensure Surgery Immunonutrition Shake supplements; Other: Daily Food Intake form |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patient participation
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start16 May 2019
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Debulking Surgery for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vance Broach, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956095
- Sponsor's protocol ID
- 19-108
- Status last verified
- Dec 2025
- First submitted
- 17 May 2019
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Nutrition Intervention for Patients Undergoing Primary Surgical Debulking of Ovarian Cancer: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03956095
- Acronym / sponsor ID
- 19-108
- Conditions
- Debulking Surgery for Ovarian Cancer
- Keywords
- Nutritional Supplement Shakes, 19-108
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ensure Surgery Immunonutrition Shake supplements | – | Dietary Supplement: Ensure Surgery Immunonutrition Shake supplements, Other: Daily Food Intake formParticipants will be provided with and instructed to drink three Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will include those who present to MSK for primary surgical management of ovarian cancer.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensure Surgery Immunonutrition Shake supplementsThree Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure. | Dietary supplement | Ensure Surgery Immunonutrition Shake supplements |
| Daily Food Intake formOn 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. | Other | Ensure Surgery Immunonutrition Shake supplements |
Primary outcome
rate of patient participation
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vance Broach, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Debulking Surgery for Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of patient participation (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.