Esophageal Neoplasms
Conditions
Interventions
This is a randomized, double-blind, prospective, placebo-controlled clinical trial with a parallel-group design. After signing the Informed Consent Form (ICF), a total of 30 (thirty) patients diagnose
Sponsors
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients - 18 years of age or older; of both sexes; with a confirmed diagnosis of stage III or IV esophageal cancer, without metastases; who are undergoing concomitant chemoradiotherapy; exclusively using enteral nutrition; participants must have adequate physical and cognitive conditions to perform the proposed tests; and agree to participate voluntarily in the study by signing the Informed Consent Form
Exclusion criteria
Exclusion criteria: Individuals with distant metastases; senility or any condition that causes an inability to understand the procedures; inability to adhere to the protocol or refusal of treatment; history of previous thoracic radiotherapy; presence of active collagenosis; clinical conditions that prevent safe participation in assessments; use of parenteral nutrition or exclusively oral feeding; as well as concomitant participation in other clinical trials that may interfere with the results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation in skeletal muscle mass is expected, verified by the change in the cross-sectional area of ??the muscle at the level of the third lumbar vertebra (L3), measured in square centimeters (cm²) by Computed Tomography, from the comparison of values ??obtained at the beginning (baseline) and at the end of the 9-week intervention.;Changes in systemic inflammatory markers are expected, verified through analysis of serum concentrations of C-Reactive Protein (CRP) and Interleukin-6 (IL-6) by Flow Cytometry at baseline, mid-week (week 5), and end of the intervention (week 9), evaluating the modulation of the inflammatory response throughout the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactMarco Dias-Peixoto
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Outcome results
None listed