Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

National Cancer Centre, Singapore

Status: Completed

Conditions: Peritoneal Metastases

Treatments: Dietary Supplement: ENSURE; Dietary Supplement: IMPACT immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03430128

2016/3063

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Oral IMPACT

Experimental group

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.

Treatment:

Dietary Supplement: IMPACT immunotherapy

Standard Nutrition (ENSURE)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: ENSURE