Cachexia
Conditions
Interventions
This study will be conducted as a randomized, double-blind, multicenter, controlled clinical trial. Fifty adult patients diagnosed with malignant gastrointestinal neoplasms, eligible for curative surg
Sponsors
Faculdade de Medicina da Universidade de São Paulo - FMUSP
Faculdade de Medicina da Universidade de São Paulo - FMUSP
Irmandade da Santa Casa de Misericordia de São Paulo
Hospital Universitário da Universidade de São Paulo
Secretaria da Saúde/Hospital Heliópolis
Instituto do Câncer Arnaldo Vieira de Carvalho
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients over 18 years of age; diagnosed with gastric or colorectal malignancy; indicated for curative surgery
Exclusion criteria
Exclusion criteria: Individuals with less than 30 days available for supplementation; patients undergoing chemotherapy; continuous use of opioids; anti-inflammatory drugs or corticosteroids; use of antibiotics; prebiotics; probiotics or synbiotics within the last three months; presence of hepatic or renal failure; diagnosis of chronic inflammatory disease; comorbidities associated with cachexia such as rheumatoid arthritis; chronic obstructive pulmonary disease; acquired immunodeficiency syndrome; autoimmune diseases; dietary or therapeutic restrictions that interfere with the study parameters
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main primary outcome: to evaluate the modulation of the composition and diversity of the intestinal microbiota after tributyrin supplementation, through sequencing of the 16S ribosomal ribonucleic acid (16S rRNA) gene, considering a positive outcome when statistically significant changes are observed in the alpha diversity indices, beta diversity indices, and in the relative abundance of specific bacterial taxa, especially butyrate-producing bacteria, in the comparison between the pre- and post-intervention periods between the intervention group and the control group;To evaluate the modulation of the systemic inflammatory profile after tributyrin supplementation, through plasma quantification of cytokines and chemokines, considering a positive outcome when a statistically significant reduction in the levels of pro-inflammatory markers, such as interleukin-6 and C-reactive protein, is observed in the supplemented group compared to the control group at the end of the four-week intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate changes in nutritional status and body composition using anthropometric methods and bioelectrical impedance analysis, with a positive outcome considered to be the maintenance or slight improvement in lean mass and/or stabilization of body weight during the preoperative period;To investigate the effects of tributyrin supplementation on plasma and fecal levels of short-chain fatty acids, determined by gas chromatography coupled with mass spectrometry, with an expected increase in plasma levels and a reduction in fecal levels of these fatty acids, especially butyrate, indicating greater intestinal absorption;To assess the participants' overall clinical condition, subjective nutritional status, and quality of life through the application of standardized questionnaires, with a positive outcome considered to be an improvement in global functionality scores and/or a reduction in symptoms related to inflammatory and nutritional status in the post-supplementation period compared to the initial assessment | — |
Countries
Brazil
Contacts
Public ContactFlaydson Pinto
Faculdade de Medicina da Universidade de São Paulo - FMUSP
Outcome results
None listed