Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

NCT03430128 | Completed

• 1 other identifier: 2016/3063
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Metastases

Outcome Measures

Primary Outcomes (1)

• Baseline wound infection rates

  From date of surgery to date that wound is healed, up to 30 days from surgery

Secondary Outcomes (2)

• Peri-operative complications

  Within 30 days from surgery

• Length of stay

  100 days

Study Arms (2)

Oral IMPACT

EXPERIMENTAL

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

Standard Nutrition (ENSURE)

ACTIVE COMPARATOR

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

Interventions

IMPACT immunotherapy DIETARY_SUPPLEMENT

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

Oral IMPACT

ENSURE DIETARY_SUPPLEMENT

Liquid milk formula available over the counter

Standard Nutrition (ENSURE)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

Study Officials

• Melissa Teo, MD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators and the clinical team which manages the patient, will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 12, 2018
• Study Start: April 23, 2017
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)