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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|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|
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
- Baseline wound infection rates [ Time Frame: From date of surgery to date that wound is healed, up to 30 days from surgery ]
- Peri-operative complications [ Time Frame: Within 30 days from surgery ]
- Length of stay [ Time Frame: 100 days ]
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
|National Cancer Centre Singapore|
|Singapore, Singapore, 169610|
|Principal Investigator:||Melissa Teo, MD||National Cancer Centre, Singapore|