Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

Peritoneal Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430128
• Other study ID #: 2016/3063
• Status: Completed
• Phase: N/A
• Start date: April 23, 2017
• Est. completion date: January 22, 2019

Study information

• Verified date: September 2019
• Source: National Cancer Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Peritoneal Metastases

Intervention

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.
• ENSURE
Liquid milk formula available over the counter

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline wound infection rates		From date of surgery to date that wound is healed, up to 30 days from surgery
Secondary	Peri-operative complications		Within 30 days from surgery
Secondary	Length of stay		100 days