Weight loss
Conditions
Interventions
Double-blind, randomized, placebo-controlled study involving patients with gastrointestinal cancer, with or without cachexia. Volunteers will be randomly assigned to two groups: the Cancer with Cachex
and the Cancer Without Cachexia Group (CL n=30), who will receive 6g of leucine (CP n=15) or 6g of placebo (n=15). At the end of the study, there will be four groups: (CXL, CXP, CL, CP). These will be
G07.203.300.456
Sponsors
Faculdade de Medicina da Universidade de São Paulo
Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: Patients with gastrointestinal cancer (stomach, esophagus, colon, or rectum), with and without weight loss. Ages between 40 and 90 years. Both sexes
Exclusion criteria
Exclusion criteria: Neoplasms of organs adjacent to the gastrointestinal tract, such as the pancreas, liver, or small intestine. Autoimmune diseases, obesity, inflammatory bowel disease, Crohn's disease, acquired immunodeficiency syndrome, chronic obstructive pulmonary disease (COPD), and other inflammatory diseases were excluded. The presence of other types of cancer, kidney or liver failure, psychotic disorders, or dementia, as well as any cognitive condition that compromises the ability to respond to the questionnaires, was also considered an exclusion criterion. Individuals who used anti-inflammatory drugs or corticosteroids during the supplementation period were excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Leucine supplementation is expected to modulate serum inflammatory cytokine expression using multiplex analysis and gut microbiota composition using 16S analysis. Additionally, patients' depression and anxiety scores will be assessed through questionnaires | — |
Secondary
| Measure | Time frame |
|---|---|
| Leucine supplementation is expected to modulate the expression of serum inflammatory cytokines and the composition of the intestinal microbiota | — |
Countries
Brazil
Contacts
Public ContactMárcia Andrade
Universidade de São Paulo
Outcome results
None listed