Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-23

Study Completion Date

2019-01-22

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.

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Detailed Description

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Conditions

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Peritoneal Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Study Groups

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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.

Group Type EXPERIMENTAL

IMPACT immunotherapy

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type ACTIVE_COMPARATOR

ENSURE

Intervention Type DIETARY_SUPPLEMENT

Liquid milk formula available over the counter

Interventions

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IMPACT immunotherapy

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

ENSURE

Liquid milk formula available over the counter

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No