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A clinical study to investigate the effects of oral immunonutrients during the perioperative period of patients with gastrointestinal cancer

Effects of enteral supplementation with immunonutrients in the perioperative course of patients with cancer of the gastrointestinal tract: A double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6sz8zht
Enrollment
Unknown
Registered
2024-05-10
Start date
2024-07-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Neoplasms

Interventions

This will be a clinical, longitudinal, prospective, analytical, controlled, randomized, 1:1 allocation (with a sample size of 243 patients), double-blind trial to be carried out in some hospitals in t
G07.203.650.240.732

Sponsors

Universidade do Estado da Bahia
Lead Sponsor
Universidade do Estado da Bahia
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged over 18 years will be included; with anatomopathological examination that shows any histological type of cancer of the gastrointestinal tract; who will undergo any curative and elective surgical procedure

Exclusion criteria

Exclusion criteria: Pregnant women will be excluded; people submitted to the use of artificial nutrition in the 15 days prior to inclusion in the study; people allergic to any components of the diet; people with any gastrointestinal diseases prior to the malignancy; people with immunosuppression or using immunosuppressive therapies

Design outcomes

Primary

MeasureTime frame
The main outcome of the study will be the determination of the use of INO in the perioperative period in patients with any malignant neoplasm of the GI tract, which can reduce the risk of surgical and infectious complications, resulting in better clinical outcomes.—

Secondary

MeasureTime frame
The secondary outcomes of the study will be to analyze whether the use of oral immunonutrients in the perioperative period of patients with gastrointestinal cancer can cause a decrease in mortality, length of hospital stay and hospital costs. In addition, serum levels of inflammatory markers will be analyzed (Leucometry, CRP, IL-2, IL-4, IL-6, IL-8, IL-10, INF-gamma and TNF-a) in patients with breast cancer. treated gastrointestinal tract, in order to demonstrate whether the use of INO can reduce such levels. With this, the study will discuss whether the use of INO can positively impact the levels of CD4 and CD8 lymphocytes, serum albumin.—

Countries

Brazil

Contacts

Public ContactMagno Das Mercês

Universidade do Estado da Bahia

mmerces@uneb.br+55(71)98216-3553

Outcome results

None listed

Source: REBEC (via WHO ICTRP)