PeRioperative Optimization With Nutritional Supplements for Patients Undergoing GastRointEStinal Surgery for Cancer

Gastrointestinal Cancer Clinical Trial

— PROGRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445260
• Other study ID #: 3988
• Status: Completed
• Phase: N/A
• Start date: October 17, 2018
• Est. completion date: August 30, 2020

Study information

• Verified date: September 2021
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 30, 2020
• Est. primary completion date: July 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Other:
• Nutritional Supplements
PreCovery is a carbohydrate loading nutritional supplement, INergy FLD is an immunonutrition formulated liquid diet, and ISOlution is a protein supplement.
• Placebo
Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of Hospital Stay	Will be determined for each patient.	1 month after index surgery