Clinical trial NCT03956095: Study of Nutritional Supplement Shakes in People About to Receive Their Debulking Surgery for Ovarian Cancer
Official title: Preoperative Nutrition Intervention for Patients Undergoing Primary Surgical Debulking of Ovarian Cancer: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Debulking Surgery for Ovarian Cancer
Keywords: Nutritional Supplement Shakes
19-108
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will include those who present to MSK for primary surgical management of ovarian cancer.

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.


Eligibility criteria: 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

Primary outcomes:
measure: rate of patient participation
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Alliance MCI
state: Florida
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Vance Broach, MD
role: PRINCIPAL_INVESTIGATOR
References: