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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03956095
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

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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 2021
Estimated Study Completion Date : May 2021


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.




Primary Outcome Measures :
  1. rate of patient participation [ Time Frame: 30 days after surgery ]

Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956095


Contacts
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Contact: Vance Broach, MD 212-639-6876 broachv@mskcc.org
Contact: Kara Long Roche, MD 212-639-7043

Locations
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United States, New Jersey
Memorial Sloan Kettering Cancer Center (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Vance Broach, MD    212-639-6876      
Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Vance Broach, MD    212-639-6876      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Vance Broach, MD    212-639-6876      
United States, New York
Memorial Sloan Kettering Commack (Limited Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Vance Broach, MD    212-639-6876      
Memoral Sloan Kettering Westchester (Limited 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 (Limited 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
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Principal Investigator: Vance Broach, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03956095    
Other Study ID Numbers: 19-108
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Nutritional Supplement Shakes
19-108
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type