Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

Not Applicable

Completed

• Conditions: Peritoneal Metastases
• Interventions: Dietary Supplement: IMPACT immunotherapy; Dietary Supplement: ENSURE

• Registration Number: NCT03430128
• Lead Sponsor: National Cancer Centre, Singapore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-23
• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-12
• Primary Completion: 2019-01-22
• Study Completion: 2019-01-22
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral IMPACT	IMPACT immunotherapy	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 Nutrition (ENSURE)	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.

Primary Outcome Measures

Name	Time	Method
Baseline wound infection rates	From date of surgery to date that wound is healed, up to 30 days from surgery

Secondary Outcome Measures

Name	Time	Method
Length of stay	100 days
Peri-operative complications	Within 30 days from surgery

Trial Locations

Locations (1)

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore