Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

Sponsor

National Cancer Centre, Singapore (Other)

Overall Status

Completed

CT.gov ID

NCT03430128

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Metastases	Dietary Supplement: IMPACT immunotherapy Dietary Supplement: ENSURE	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 23, 2017

Actual Primary Completion Date :

Jan 22, 2019

Actual Study Completion Date :

Jan 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: IMPACT immunotherapy Powdered formula that is pre-packaged in individual packets which the patients will be instructed to mix with water before consumption.
Active Comparator: 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.	Dietary Supplement: ENSURE Liquid milk formula available over the counter

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: IMPACT immunotherapy

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

Active Comparator: 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.

Dietary Supplement: ENSURE

Liquid milk formula available over the counter

Outcome Measures

Primary Outcome Measures

Baseline wound infection rates [From date of surgery to date that wound is healed, up to 30 days from surgery]

Secondary Outcome Measures

Peri-operative complications [Within 30 days from surgery]
Length of stay [100 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Centre Singapore	Singapore		Singapore	169610

Sponsors and Collaborators

National Cancer Centre, Singapore

Investigators

Principal Investigator: Melissa Teo, MD, National Cancer Centre, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Cancer Centre, Singapore

ClinicalTrials.gov Identifier:

NCT03430128

Other Study ID Numbers:

2016/3063

First Posted:

Feb 12, 2018

Last Update Posted:

Sep 20, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Study Results

No Results Posted as of Sep 20, 2019