PeRioperative Optimization With Nutritional Supplements for Patients Undergoing GastRointEStinal Surgery for Cancer (PROGRESS)

PeRioperative Optimization With Nutritional Supplements in Patients Undergoing GastRointEStinal Surgery for Cancer (PROGRESS): A Randomized Placebo Controlled Feasibility Study.

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Cancer
• Intervention / Treatment: Other: Placebo; Other: Nutritional Supplements

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V1C3
      • Hamilton Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.	Other: Placebo; Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.
Experimental: Nutritional Supplements; 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.; Other Names: PreCovery; INergy FLD; ISOlution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	21 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline, 1 month, and 3 months after index surgery
Length of Hospital Stay	Will be determined for each patient.	1 month after index surgery

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation

Publications and helpful links

General Publications

• Serrano PE, Parpia S, Nair S, Ruo L, Simunovic M, Levine O, Duceppe E, Rodrigues C. Perioperative Optimization With Nutritional Supplements in Patients Undergoing Gastrointestinal Surgery for Cancer (PROGRESS): Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 31;7(10):e10491. doi: 10.2196/10491.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2018
• Primary Completion (Actual): July 22, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: 3988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No