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Trial record 1 of 1 for:    immunonutrition hipec
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Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03430128
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Centre, Singapore

Tracking Information
First Submitted Date  ICMJE January 30, 2018
First Posted Date  ICMJE February 12, 2018
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE April 23, 2017
Actual Primary Completion Date January 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
Baseline wound infection rates [ Time Frame: From date of surgery to date that wound is healed, up to 30 days from surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03430128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
  • Peri-operative complications [ Time Frame: Within 30 days from surgery ]
  • Length of stay [ Time Frame: 100 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC
Official Title  ICMJE Perioperative Immunonutrition for Patients Undergoing Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Peritoneal Metastases
Intervention  ICMJE
  • 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.
  • Dietary Supplement: ENSURE
    Liquid milk formula available over the counter
Study Arms  ICMJE
  • 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.

    Intervention: Dietary Supplement: IMPACT immunotherapy
  • 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.
    Intervention: Dietary Supplement: ENSURE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 22, 2019
Actual Primary Completion Date January 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03430128
Other Study ID Numbers  ICMJE 2016/3063
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National Cancer Centre, Singapore
Study Sponsor  ICMJE National Cancer Centre, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melissa Teo, MD National Cancer Centre, Singapore
PRS Account National Cancer Centre, Singapore
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP