NCT04027088

Brief Summary

Randomized, double-blind, multicenter clinical trial that will evaluate the effects of immuno-nutrition in the preoperative period in patients with cancer of the upper digestive tract (esophagus, stomach, and pancreas). The aim is to compare the specific effect of the immunonutrients respect to an equivalent formula in caloric-protein value but without immunonutrients, in the surgical evolution of the cancer patient.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

August 10, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

July 16, 2019

Last Update Submit

August 19, 2019

Conditions

ImmunonutritionGastric CancerEsophageal CancerPancreas CancerSurgery--Complications

Keywords

immunonutritionsurgerypostoperative complicationslength of hospital staynutritional status

Outcome Measures

Primary Outcomes (2)

  • Infectious complications

    Up to 30 days post-operative

  • Surgical fistulas

    Up to 30 days post-operative

Secondary Outcomes (3)

  • Mortality

    Up to 30 days post-operative

  • Length of hospital stay

    Up to 30 days post-operative

  • Weight loss

    10 days Pre-operative

Study Arms (2)

Immunonutrition

EXPERIMENTAL

Oral nutritional supplement: hypercaloric and hyperproteic with immunonutrients: Arginine, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine

Dietary Supplement: Immunonutrition

Standard

PLACEBO COMPARATOR

Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients

Dietary Supplement: Standard

Interventions

ImmunonutritionDIETARY_SUPPLEMENT

It is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine

Also known as: Bi1 procare
Immunonutrition
StandardDIETARY_SUPPLEMENT

It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients

Standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of cancer of esophagus, stomach and / or pancreas, at any stage, proposed for surgery
  • Signing informed consent

You may not qualify if:

  • Pregnant or breastfeeding
  • Advanced renal insufficiency prior to dialysis (GFR \<25 ml / min)
  • Allergy or intolerance to any of the components of the dietary supplement (including fish allergy)
  • Patients with contraindications for enteral nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Miguel A. Martínez Olmos

Santiago de Compostela, A Coruña, 15701, Spain

RECRUITING

Alfonso Vidal-Casariego

A Coruña, La Coruna, 15006, Spain

RECRUITING

Related Publications (1)

  • Villar-Taibo R, Vidal-Casariego A, Santamaria-Nieto A, Canton-Blanco A, Crujeiras AB, Lugo Rodriguez G, Rodriguez-Carnero G, Pita Gutierrez F, Fernandez Pombo A, Diaz-Lopez E, Roman Eyo A, Rodriguez Lavandeira U, Pena-Dubra A, Martinez-Olmos MA. Efficacy of a new immunonutrition formula with extra virgin olive oil in the reduction of complications in surgeries of upper digestive tract tumors. Front Nutr. 2024 May 28;11:1384145. doi: 10.3389/fnut.2024.1384145. eCollection 2024.

    PMID: 38863591DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal NeoplasmsPancreatic NeoplasmsPostoperative Complications

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Miguel Á Martínez-Olmos, PhD, MD

    Complexo Hospitalario Universitario de Santiago

    PRINCIPAL INVESTIGATOR

  • Alfonso Vidal-Casariego, PhD, MD

    Complexo Hospitalario Universitario de A Coruña

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfonso Vidal-Casariego, PhD, MD

CONTACT

+34981176442alfonso.vidal.casariego@sergas.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Alfonso Vidal Casariego, MD PhD

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 19, 2019

Study Start

August 10, 2019

Primary Completion

August 10, 2021

Study Completion

December 31, 2021

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)