Cachexia
Conditions
Interventions
Eighty subjects will be randomized in two groups (1:1) through a minimization method, using center, sex and cachexia degree as stratification factors. Intervention arm: 40 participants will receive 12
and participant’s ID is a unique random alphanumeric code that does not allow identification of the study arm to which is assigned.
G07.203.300.456
Sponsors
Universidade Federal de São Paulo
Hospital Guilherme Álvaro
Eligibility
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: Histopathological diagnosis of colorectal carcinoma; Indication of curative surgery for resection of malignant primary colorectal tumor; Tumor classification according to the Union for Internacional Cancer Control (UICC) criteria; Pre-cachexia or cachexia diagnosis (2011 Consensus); Age between 40 and 90 years; Signed Informed Consent;
Exclusion criteria
Exclusion criteria: Confirmed distant metastasis; Radio/Chemotherapy treatment in the last 3 months; Body Mass Index (BMI) greater than 40 kg/m²; History of liver function impairment (Child-Pugh-Turcotte score B and C); History of chronic kidney disease (defined according KDIGO 2012); HIV positive with AIDS-related complications; Hypersensitivity to trial supplement; Continuous supplementation of polyphenols or pre/probiotics in the last 3 months; Inflammatory bowel diseases (IBD) or chronic inflammatory processes unrelated to cachexia, such as autoimmune disorders; Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the reduction in mean body weight loss (kg) in the period between the first (Day 1) and last visit (Day 56), verified by Generalized Linear Mixed Model (GLMM) | — |
Secondary
| Measure | Time frame |
|---|---|
| Describe the number and severity of adverse events (AEs) and serious AEs during the intervention (day 1 to day 56), evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE), based on weekly assessments through the measurement system Patient-Reported Outcomes version of the CTCAE. Proportion of events and its severity will be described for each study arm.;Evaluate reduction in mean free-fat mass loss (kg) in the period between the first (Day 1) and last visit (Day 56), measured by Bioimpedance Analysis (Biodynamics BIA 450 Bioimpedance Analyzer), and verified by Generalized Linear Mixed Model (GLMM) ;Evaluate reduction in mean handgrip strength loss (kg) in the period between the first (Day 1) and last visit (Day 56), measured by Jamar® 5030J1 hydraulic hand dynamometer, and verified by Generalized Linear Mixed Model (GLMM);Assess quality of life preservation (mean score) in the period between the first (Day 1) and last visit (Day 56), measured by the EORTC QLQ-C30 and CAX24 questionnaires, verified by Generalized Generalized Linear Model (GLMM).;Evaluate fatigue attenuation (mean score) in the period between the first (Day 1) and last visit (Day 56), measured by the FACIT-F questionnaire, verified by Generalized Generalized Linear Model (GLMM).;Evaluate anorexia attenuation (mean score) in the period between the first (Day 1) and last visit (Day 56), measured by the Appetite Visual Analogue Scale and by the subdomain of the EORTC QLQ-CAX24 questionnaire, verified by Generalized Generalized Linear Model (GLMM).;It is expected to reduce the number of occurrences and the grade of postoperative complications (mean score) in the period between the first (Day 1) and last visit (Day 56), measured by the Comprehensive Complication Index, and verified by Generalized Generalized Linear Model (GLMM). | — |
Countries
Brazil
Contacts
Public ContactDaniela Gonçalves
Universidade Federal de São Paulo
Outcome results
None listed