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Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

Primary Purpose

Peritoneal Metastases

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

IMPACT immunotherapy

ENSURE

About this trial

This is an interventional supportive care trial for Peritoneal Metastases

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients planned for CRS and HIPEC, with sufficient time (5 to 7 days) prior to surgery for start of nutritional supplements are eligible
All patients must be able to provide informed consent
There are no restrictions to use of contraception

Exclusion Criteria:

Patients who are not able to provide informed consent will be excluded.
Patients with a diagnosis of diabetes mellitus will be excluded.
Patients not fit for surgery or those who undergo surgery under emergency situations will be excluded.
Patients who have intestinal obstruction and not able to consume the nutritional supplements orally will be excluded.

Sites / Locations

National Cancer Centre Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral IMPACT

Standard Nutrition (ENSURE)

Arm Description

Perioperative immunonutrition will commence 5-7 days prior to surgery, and will continue for 5-7 days post-surgery, as soon as the patient is able to consume full feeds as instructed by his/her primary physician. The recommended dose for IMPACT immunotherapy is one packet, to be taken three times a day.

Standard nutritional supplementation will commence 5-7 days prior to surgery, and will continue for 5-7 days post-surgery, as soon as the patient is able to consume full feeds as instructed by his/her primary physician.

Outcomes

Primary Outcome Measures

Baseline wound infection rates

Secondary Outcome Measures

Peri-operative complications

Length of stay

Full Information

NCT ID

NCT03430128

First Posted

January 30, 2018

Last Updated

September 18, 2019

Sponsor

National Cancer Centre, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT03430128

Brief Title

Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

Official Title

Perioperative Immunonutrition for Patients Undergoing Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

April 23, 2017 (Actual)

Primary Completion Date

January 22, 2019 (Actual)

Study Completion Date

January 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Centre, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Patients with peritoneal disease commonly present with symptoms of abdominal distension and subacute intestinal obstruction. This results in poor oral intake leading to these patients often presenting in a malnourished state. CRS and HIPEC can potential provide improve survival for these patients, however can be a hazardous procedure, involving multi-organ resections. The risk is especially high in poorly nourished patients. The study investigators hypothesize that perioperative immunonutrition can reduce wound infections and length of hospital stay, and improve perioperative outcomes. To the investigators' knowledge, it has not been evaluated in patients undergoing CRS and HIPEC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peritoneal Metastases

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The investigators and the clinical team which manages the patient, will be blinded.

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral IMPACT

Arm Type

Experimental

Arm Description

Arm Title

Standard Nutrition (ENSURE)

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

IMPACT immunotherapy

Intervention Description

Powdered formula that is pre-packaged in individual packets which the patients will be instructed to mix with water before consumption.

Intervention Type

Dietary Supplement

Intervention Name(s)

ENSURE

Intervention Description

Liquid milk formula available over the counter

Primary Outcome Measure Information:

Title

Baseline wound infection rates

Time Frame

From date of surgery to date that wound is healed, up to 30 days from surgery

Secondary Outcome Measure Information:

Title

Peri-operative complications

Time Frame

Within 30 days from surgery

Title

Length of stay

Time Frame

100 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients planned for CRS and HIPEC, with sufficient time (5 to 7 days) prior to surgery for start of nutritional supplements are eligible All patients must be able to provide informed consent There are no restrictions to use of contraception Exclusion Criteria: Patients who are not able to provide informed consent will be excluded. Patients with a diagnosis of diabetes mellitus will be excluded. Patients not fit for surgery or those who undergo surgery under emergency situations will be excluded. Patients who have intestinal obstruction and not able to consume the nutritional supplements orally will be excluded.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melissa Teo, MD

Organizational Affiliation

National Cancer Centre, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Centre Singapore

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

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