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OpenTrials
Completed

NCT Number: NCT03430128

Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

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.

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Key information

Conditions

Peritoneal Metastases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Centre Singapore

Singapore, 169610

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Ensure

Dietary Supplement

Liquid milk formula available over the counter

Primary outcomes

  1. Baseline wound infection rates

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

Secondary outcomes

  1. Peri-operative complications

    Time frame: Within 30 days from surgery

  2. Length of stay

    Time frame: 100 days

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2018
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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