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

1. september 2021 opdateret af: Pablo Serrano, Hamilton Health Sciences Corporation

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

73

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.
Andet: Placebo
Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.
Eksperimentel: Nutritional Supplements
carbohydrate loading, immunonutrition (formulated liquid diet), protein supplement
Andet: Nutritional Supplements
PreCovery is a carbohydrate loading nutritional supplement, INergy FLD is an immunonutrition formulated liquid diet, and ISOlution is a protein supplement.
Andre navne:
  • PreCovery
  • INergy FLD
  • ISOlution

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The number of patients randomized to the study
Tidsramme: 21 months
Feasibility of this study will be determined by the number of eligible patients randomized to intervention or placebo.
21 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The number of patients who comply with the study intervention regimen
Tidsramme: 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.
30 days before index surgery, and up to 5 days after index surgery
Overall Complications
Tidsramme: 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 months after index surgery
Comprehensive Complication Index
Tidsramme: 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.
3 months after index surgery
Quality of Life (QoL) - EORTC-QLQ-C Instrument
Tidsramme: 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.
Baseline, 1 month, and 3 months after index surgery
Quality of Life (QoL) - FACT-G Scale
Tidsramme: 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.
Baseline, 1 month, and 3 months after index surgery
Length of Hospital Stay
Tidsramme: 1 month after index surgery
Will be determined for each patient.
1 month after index surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hamilton Health Sciences Corporation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. oktober 2018

Primær færdiggørelse (Faktiske)

22. juli 2020

Studieafslutning (Faktiske)

30. august 2020

Datoer for studieregistrering

Først indsendt

21. december 2017

Først indsendt, der opfyldte QC-kriterier

22. februar 2018

Først opslået (Faktiske)

26. februar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. september 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3988

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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