Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

Study Overview
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Brief Summary
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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.

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

Conditions
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Peritoneal Metastases

Intervention / Treatment
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* Dietary Supplement: IMPACT immunotherapy
* Dietary Supplement: ENSURE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral IMPACT<br>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<br>* Powdered formula that is pre-packaged in individual packets which the patients will be instructed to mix with water before consumption.<br>|
| Active Comparator: Standard Nutrition (ENSURE)<br>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<br>* Liquid milk formula available over the counter<br>|

What is the study measuring?
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Primary Outcome Measures

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