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Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

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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

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : April 23, 2017
Actual Primary Completion Date : January 22, 2019
Actual Study Completion Date : January 22, 2019

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




Primary Outcome Measures :
  1. Baseline wound infection rates [ Time Frame: From date of surgery to date that wound is healed, up to 30 days from surgery ]

Secondary Outcome Measures :
  1. Peri-operative complications [ Time Frame: Within 30 days from surgery ]
  2. Length of stay [ Time Frame: 100 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430128


Locations
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Singapore
National Cancer Centre Singapore
Singapore, Singapore, 169610
Sponsors and Collaborators
National Cancer Centre, Singapore
Investigators
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Principal Investigator: Melissa Teo, MD National Cancer Centre, Singapore

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Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT03430128     History of Changes
Other Study ID Numbers: 2016/3063
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes