Status:
COMPLETED
PeRioperative Optimization With Nutritional Supplements for Patients Undergoing GastRointEStinal Surgery for Cancer
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Gastrointestinal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single-center randomized, placebo-controlled, double-blind feasibility study comparing the intervention of perioperative nutritional supplements (immunomodulation, carbohydrate loading, and ...
Eligibility Criteria
Inclusion
- Men and women 18 years of age or older
- Diagnosed with a resectable type of gastrointestinal cancer (e.g. cancers of the gallbladder, liver, pancreas, stomach, small intestine, colon and rectum) for which an elective operation is planned (resection vs. palliative procedure).
- Patients with distant metastasis are eligible for the study.
- Patients who are lactose intolerant are also eligible for the study because the amount of lactose in ISOlution and PreCovery is minimal (trace).
Exclusion
- Malabsorption syndrome (e.g. chronic pancreatitis)
- Cannot tolerate oral intake (e.g. gastric outlet obstruction or delayed gastric emptying)
- Organ failure (liver, kidney); end stage liver disease with a Child Pugh Score ≥ B or end stage renal disease defined as stages 3 and 4 with a glomerular filtration rate between 30-59 for stage 3 and 15-29 for stage 4.
- Inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematous, Crohn's disease and ulcerative colitis
- Patients currently on steroids
- Poorly controlled type 1 or 2 diabetes mellitus
- Female patients who are pregnant and/or lactating
- Galactosemia
- Ongoing infection.
Key Trial Info
Start Date :
October 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03445260
Start Date
October 17 2018
End Date
August 30 2020
Last Update
September 2 2021
Active Locations (1)
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1
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V1C3