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出境医 / 临床实验 / Study of Nutritional Supplement Shakes in People About to Receive Their Debulking Surgery for Ovarian Cancer
Study of Nutritional Supplement Shakes in People About to Receive Their Debulking Surgery for Ovarian Cancer
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Debulking Surgery for Ovarian Cancer | Dietary Supplement: Ensure Surgery Immunonutrition Shake supplements Other: Daily Food Intake form |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 30 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Preoperative Nutrition Intervention for Patients Undergoing Primary Surgical Debulking of Ovarian Cancer: A Feasibility Study |
| Actual Study Start Date : | May 16, 2019 |
| Estimated Primary Completion Date : | May 2023 |
| Estimated Study Completion Date : | May 2023 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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.
|
Dietary Supplement: Ensure Surgery Immunonutrition Shake supplements
Three Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure.
Other: 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.
|
Outcome Measures
Primary Outcome Measures :
- rate of patient participation [ Time Frame: 30 days after surgery ]
Biospecimen Retention: Samples Without DNA
Blood
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Ovarian Cancer |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Eligible patients will include those who present to MSK for primary surgical management of ovarian cancer.
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
Contacts and Locations
Contacts
| Contact: Vance Broach, MD | 212-639-6876 | broachv@mskcc.org | |
| Contact: Kara Long Roche, MD | 212-639-7043 |
Locations
| United States, Florida | |
| Baptist Alliance MCI | Recruiting |
| Miami, Florida, United States, 33143 | |
| Contact: John Diaz, MD 786-596-2000 | |
| United States, New Jersey | |
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | Recruiting |
| Basking Ridge, New Jersey, United States, 07920 | |
| Contact: Vance Broach, MD 212-639-6876 | |
| Memorial Sloan Kettering Monmouth (All Protocol Activities) | Recruiting |
| Middletown, New Jersey, United States, 07748 | |
| Contact: Vance Broach, MD 212-639-6876 | |
| Memorial Sloan Kettering Bergen (All Protocol Activities) | Recruiting |
| Montvale, New Jersey, United States, 07645 | |
| Contact: Vance Broach, MD 212-639-6876 | |
| United States, New York | |
| Memorial Sloan Kettering Commack (All Protocol Activities) | Recruiting |
| Commack, New York, United States, 11725 | |
| Contact: Vance Broach, MD 212-639-6876 | |
| Memoral Sloan Kettering Westchester (All Protocol Activities) | Recruiting |
| Harrison, New York, United States, 10604 | |
| Contact: Vance Broach, MD 212-639-6876 | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Vance Broach, MD 212-639-6876 | |
| Contact: Kara Long-Roche, MD 212-639-7043 | |
| Principal Investigator: Kara Long-Roche, MD | |
| Memorial Sloan Kettering Nassau (All Protocol Activities) | Recruiting |
| Uniondale, New York, United States, 11553 | |
| Contact: Vance Broach, MD 212-639-6876 | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
| Principal Investigator: | Vance Broach, MD | Memorial Sloan Kettering Cancer Center |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 17, 2019 | ||||||||
| First Posted Date | May 20, 2019 | ||||||||
| Last Update Posted Date | April 23, 2021 | ||||||||
| Actual Study Start Date | May 16, 2019 | ||||||||
| Estimated Primary Completion Date | May 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
rate of patient participation [ Time Frame: 30 days after surgery ] | ||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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 | ||||||||
| 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 Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description:
Blood
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Eligible patients will include those who present to MSK for primary surgical management of ovarian cancer. | ||||||||
| Condition | Debulking Surgery for Ovarian Cancer | ||||||||
| Intervention |
|
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| Study Groups/Cohorts | 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:
|
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
30 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | May 2023 | ||||||||
| Estimated Primary Completion Date | May 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03956095 | ||||||||
| Other Study ID Numbers | 19-108 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Memorial Sloan Kettering Cancer Center | ||||||||
| Study Sponsor | Memorial Sloan Kettering Cancer Center | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Memorial Sloan Kettering Cancer Center | ||||||||
| Verification Date | April 2021 | ||||||||
