An interventional study of Nutritional Supplements and Placebo in Gastrointestinal Cancer, sponsored by Hamilton Health Sciences Corporation. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-02.
Sponsored by Hamilton Health Sciences Corporation · Not applicable, Interventional, and Prevention
This is a single-center randomized, placebo-controlled, double-blind feasibility study comparing the intervention of perioperative nutritional supplements (immunomodulation, carbohydrate loading, and protein isolate) with an identical placebo for each solution in patients with gastrointestinal cancer undergoing surgery. Eligible and consenting patients will be randomly allocated to receive the intervention or placebo in a 1:1 ratio.
This study will assess the feasibility of a large, multi-centre trial by establishing the feasibility of randomization to intervention or placebo. This study will be conducted at the Juravinski Hospital and will enroll 100 patients over 18 months.
The study intervention includes three perioperative nutritional supplements: (1) a protein supplement administered 3 times a day for 30 days before surgery, (2) a sugar-based supplement administered the day prior to and the day of surgery, and (3) a formulated liquid diet containing arginine, RNA, proteins and omega-6 fatty acids (referred to as immunonutrition for the purposes of this study) administered for 5 days prior to and 5 days after surgery.
The primary outcome for each eligible patient is defined as being randomized to intervention or placebo. The criteria for success of this study is defined as the proportion of eligible patients randomized as ≥ 60%. If the estimated proportion is \<40%, the trial will be considered not feasible. If the proportion is between 40%-59%, the trial will be considered feasible with modifications to improve enrolment. Other secondary objectives include compliance with study intervention, estimating differences in postoperative complications, length of hospital stay, and quality of life between groups.
Exclusion Criteria:
Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.
Other: Placebo
carbohydrate loading, immunonutrition (formulated liquid diet), protein supplement
Other: Nutritional Supplements
PreCovery is a carbohydrate loading nutritional supplement, INergy FLD is an immunonutrition formulated liquid diet, and ISOlution is a protein supplement.
Also known as: PreCovery, INergy FLD, ISOlution
Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.
The number of patients randomized to the study
Feasibility of this study will be determined by the number of eligible patients randomized to intervention or placebo.
Time frame: 21 months
The number of patients who comply with the study intervention regimen
Compliance will be defined as intake of at least 70% of study intervention regimen.
Time frame: 30 days before index surgery, and up to 5 days after index surgery
Overall Complications
Occurrence of any postoperative complication (major or minor) from surgery following each patient's hospital stay and up to 90 days from the initial operation. Occurrence of any postoperative infections will also be calculated.
Time frame: 3 months after index surgery
Comprehensive Complication Index
At 90 days from the index operation will be determined for each patient. This index can be calculated for each patient using the online calculator www.assessurgery.com25 following the grading of each postoperative complication according to Clavien-Dindo.
Time frame: 3 months after index surgery
Quality of Life (QoL) - EORTC-QLQ-C Instrument
The global health related QoL at baseline, 1 and 3 months following randomization measured using the EORTC-QLQ-C instrument.
Time frame: Baseline, 1 month, and 3 months after index surgery
Quality of Life (QoL) - FACT-G Scale
The global health related QoL at baseline, 1 and 3 months following randomization measured using the FACT-G scale.
Time frame: Baseline, 1 month, and 3 months after index surgery
Length of Hospital Stay
Will be determined for each patient.
Time frame: 1 month after index surgery
Plan to share: No
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hamilton Health Sciences Corporation