Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

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

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.

Study Overview

• Status: Completed
• Conditions: Peritoneal Metastases
• Intervention / Treatment: Dietary supplement: IMPACT immunotherapy; Dietary supplement: ENSURE

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169610
    • National Cancer Centre Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oral IMPACT; 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.	Dietary supplement: IMPACT immunotherapy; Powdered formula that is pre-packaged in individual packets which the patients will be instructed to mix with water before consumption.
ACTIVE_COMPARATOR: Standard Nutrition (ENSURE); 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.	Dietary supplement: ENSURE; Liquid milk formula available over the counter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Baseline wound infection rates	From date of surgery to date that wound is healed, up to 30 days from surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Peri-operative complications	Within 30 days from surgery
Length of stay	100 days

Collaborators and Investigators

• Sponsor: National Cancer Centre, Singapore
• Investigators: Principal Investigator: Melissa Teo, MD, National Cancer Centre, Singapore

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2017
• Primary Completion (ACTUAL): January 22, 2019
• Study Completion (ACTUAL): January 22, 2019

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (ACTUAL): February 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 2016/3063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No