ImmunonutritionNCT04027088
Effect of Preoperative Immunonutrition in Upper Digestive Tract
A study testing Immunonutrition and Standard in people with Immunonutrition and Gastric Cancer, run by Complexo Hospitalario Universitario de A Coruña at 2 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunonutrition, Gastric Cancer, Esophageal Cancer
- What is being tested?
- Immunonutrition and Standard
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 2 sitesSpain
- Study dates
- 10 Aug 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cancer of esophagus, stomach and / or pancreas, at any stage, proposed for surgery
- Signing informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Alfonso Vidal-Casariego
A Coruña, La Coruna, 15006
Alfonso Vidal-Casariego, MD, PhD, +34981176442, alfonso.vidal.casariego@sergas.es
Alfonso Vidal-Casariego, MD, PhD
- Recruiting
Miguel A. Martínez Olmos
Santiago de Compostela, A Coruña, 15701
Miguel A Martínez Olmos, MD PhD
Miguel A Martínez Olmos, MD PhD
About this study
Official title: Multicenter Randomized Clinical Trial of the Effect of Preoperative Immunonutrition Versus Standard Enteral Nutrition in Elective Oncological Surgery of the Upper Digestive Tract
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.
Read the detailed description
Background:
Perioperative nutritional status is a key factor in the evolution, as well as, postoperative morbidity and mortality of cancer patients. Particularly, digestive neoplasms have a high risk of malnutrition and this is related to a higher rate of surgery complications and mortality in the postoperative period. The immunonutrition seems to modulate the immune system and the inflammatory response in patients operated on for digestive neoplasia. However, the results to date are controversial.
Aim:
To compare the effect of an immunomodulatory oral nutritional supplement (enriched in arginine, nucleotides, omega 3 fatty acids, olive oil polyphenols, L-carnitine, and antioxidants) against an equivalent in protein-energy without immunonutrients, administrated in the preoperative period, in the surgical evolution of the cancer patient with neoplasia of the upper digestive tract.
Methods:
It is a randomized, double-blind, multicenter clinical trial. 178 patients with neoplasms of the esophagus, stomach or pancreas, with indication of surgical treatment, will be included. The patients will be randomized into two groups (intervention group and control group) and both will receive 2 daily bricks of the assigned formula (with or without immunonutrients, respectively) 5 days prior to surgery. The main variables of the study are: appearance of infectious or noninfectious complications in the postoperative period, length of hospital stay, and mortality. These variables will be compared by group (immunonutrition vs. non immunonutrition).
- Conditions
- Immunonutrition, Gastric Cancer, Esophageal Cancer, Pancreas Cancer, Surgery--Complications
- Being tested
- Immunonutrition, Standard
- Keywords
- immunonutrition, surgery, postoperative complications, length of hospital stay, nutritional status
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Pancreatic Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunonutritionDietary supplement
Also called Bi1 procare
It is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine
StandardDietary supplement
It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients
| Study group | Role | What they receive |
|---|---|---|
| Immunonutrition | Experimental | Oral nutritional supplement: hypercaloric and hyperproteic with immunonutrients: Arginine, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine Receives: Dietary Supplement: Immunonutrition |
| Standard | Placebo comparator | Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients Receives: Dietary Supplement: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious complications
Measured: Up to 30 days post-operative
Surgical fistulas
Measured: Up to 30 days post-operative
Secondary outcomes (3)
Mortality
Measured: Up to 30 days post-operative
Length of hospital stay
Measured: Up to 30 days post-operative
Weight loss
Measured: 10 days Pre-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start10 Aug 2019
- Primary completion10 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunonutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Complexo Hospitalario Universitario de A Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Vidal Casariego, Complexo Hospitalario Universitario de A Coruña
- Investigators
- Miguel Á Martínez-Olmos, PhD, MD, Principal investigator, Complexo Hospitalario Universitario de SantiagoAlfonso Vidal-Casariego, PhD, MD, Principal investigator, Complexo Hospitalario Universitario de A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027088
- Sponsor's protocol ID
- 2018/548
- Status last verified
- Aug 2019
- First submitted
- 16 Jul 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38863591
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Clinical Trial of the Effect of Preoperative Immunonutrition Versus Standard Enteral Nutrition in Elective Oncological Surgery of the Upper Digestive Tract
- ClinicalTrials.gov ID
- NCT04027088
- Acronym / sponsor ID
- 2018/548
- Conditions
- Immunonutrition, Gastric Cancer, Esophageal Cancer, Pancreas Cancer, Surgery--Complications
- Keywords
- immunonutrition, surgery, postoperative complications, length of hospital stay, nutritional status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Complexo Hospitalario Universitario de A CoruñaUniversity, hospital or other
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 10 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Perioperative nutritional status is a key factor in the evolution, as well as, postoperative morbidity and mortality of cancer patients. Particularly, digestive neoplasms have a high risk of malnutrition and this is related to a higher rate of surgery complications and mortality in the postoperative period. The immunonutrition seems to modulate the immune system and the inflammatory response in patients operated on for digestive neoplasia. However, the results to date are controversial.
Aim:
To compare the effect of an immunomodulatory oral nutritional supplement (enriched in arginine, nucleotides, omega 3 fatty acids, olive oil polyphenols, L-carnitine, and antioxidants) against an equivalent in protein-energy without immunonutrients, administrated in the preoperative period, in the surgical evolution of the cancer patient with neoplasia of the upper digestive tract.
Methods:
It is a randomized, double-blind, multicenter clinical trial. 178 patients with neoplasms of the esophagus, stomach or pancreas, with indication of surgical treatment, will be included. The patients will be randomized into two groups (intervention group and control group) and both will receive 2 daily bricks of the assigned formula (with or without immunonutrients, respectively) 5 days prior to surgery. The main variables of the study are: appearance of infectious or noninfectious complications in the postoperative period, length of hospital stay, and mortality. These variables will be compared by group (immunonutrition vs. non immunonutrition).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunonutrition | Experimental | Dietary Supplement: ImmunonutritionOral nutritional supplement: hypercaloric and hyperproteic with immunonutrients: Arginine, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine |
| Standard | Placebo comparator | Dietary Supplement: StandardOral nutritional supplement: hypercaloric and hyperproteic without immunonutrients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of cancer of esophagus, stomach and / or pancreas, at any stage, proposed for surgery
- Signing informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunonutritionAlso: Bi1 procareIt is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine | Dietary supplement | Immunonutrition |
| StandardIt is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients | Dietary supplement | Standard |
Primary outcome
Infectious complications
Time frame: Up to 30 days post-operative
Surgical fistulas
Time frame: Up to 30 days post-operative
3 secondary outcomes
Mortality
Time frame: Up to 30 days post-operative
Length of hospital stay
Time frame: Up to 30 days post-operative
Weight loss
Time frame: 10 days Pre-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Derived from this study: PubMed 38863591Villar-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Á Martínez-Olmos, PhD, MD principal investigator
Complexo Hospitalario Universitario de Santiago
Alfonso Vidal-Casariego, PhD, MD principal investigator
Complexo Hospitalario Universitario de A Coruña
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunonutrition and Standard in people with Immunonutrition and Gastric Cancer, run by Complexo Hospitalario Universitario de A Coruña at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alfonso Vidal-Casariego, PhD, MD (+34981176442, alfonso.vidal.casariego@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious complications (time frame: Up to 30 days post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04027088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.