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

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ClinicalTrials.gov Identifier: NCT03445260
Recruitment Status : Not yet recruiting
First Posted : February 26, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Pablo Serrano, Hamilton Health Sciences Corporation

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.


Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Other: Nutritional Supplements Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PeRioperative Optimization With Nutritional Supplements in Patients Undergoing GastRointEStinal Surgery for Cancer (PROGRESS): A Randomized Placebo Controlled Feasibility Study.
Estimated Study Start Date : September 15, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The number of patients randomized to the study [ Time Frame: 21 months ]
    Feasibility of this study will be determined by the number of eligible patients randomized to intervention or placebo.


Secondary Outcome Measures :
  1. The number of patients who comply with the study intervention regimen [ Time Frame: 30 days before index surgery, and up to 5 days after index surgery ]
    Compliance will be defined as intake of at least 70% of study intervention regimen.

  2. Overall Complications [ Time Frame: 3 months after index surgery ]
    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. Comprehensive Complication Index [ Time Frame: 3 months after index surgery ]
    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.

  4. Quality of Life (QoL) - EORTC-QLQ-C Instrument [ Time Frame: Baseline, 1 month, and 3 months after index surgery ]
    The global health related QoL at baseline, 1 and 3 months following randomization measured using the EORTC-QLQ-C instrument.

  5. Quality of Life (QoL) - FACT-G Scale [ Time Frame: Baseline, 1 month, and 3 months after index surgery ]
    The global health related QoL at baseline, 1 and 3 months following randomization measured using the FACT-G scale.

  6. Length of Hospital Stay [ Time Frame: 1 month after index surgery ]
    Will be determined for each patient.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445260


Locations
Canada, Ontario
Hamilton Health Sciences Not yet recruiting
Hamilton, Ontario, Canada, L8V1C3
Contact: Pablo E Serrano, MD    905-521-2100 ext 43872    serrano@mcmaster.ca   
Contact: Marlie Valencia, BHSc    905-521-2100 ext 43921    valencmg@mcmaster.ca   
Principal Investigator: Pablo E Serrano, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pablo Serrano, Assistant Professor, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT03445260     History of Changes
Other Study ID Numbers: 3988
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases