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

NCT03445260 | Completed

• 1 other identifier: 3988
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The number of patients who comply with the study intervention regimen

  30 days before index surgery, and up to 5 days after index surgery

• Overall Complications

  3 months after index surgery

• Comprehensive Complication Index

  3 months after index surgery

• Quality of Life (QoL) - EORTC-QLQ-C Instrument

  Baseline, 1 month, and 3 months after index surgery

• Quality of Life (QoL) - FACT-G Scale

  Baseline, 1 month, and 3 months after index surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.

Other: Placebo

Nutritional Supplements

EXPERIMENTAL

carbohydrate loading, immunonutrition (formulated liquid diet), protein supplement

Other: Nutritional Supplements

Interventions

Nutritional Supplements OTHER

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

Nutritional Supplements

Placebo OTHER

Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8V1C3, Canada

Location

Related Publications (1)

• 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.

  PMID: 30381282 DERIVED

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: February 26, 2018
• Study Start: October 17, 2018
• Primary Completion: July 22, 2020
• Study Completion: August 30, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)