Weight loss
Conditions
Interventions
A double-blind, randomized, placebo-controlled study. The Dr. Arnaldo Vieira de Carvalho Cancer Institute (ICAVC) will be held in São Paulo. Adult patients aged between 50 and 80 years old, of both se
G07.203.300.456
Sponsors
Márcia Fábia Andrade Santos
Ajinomoto do Brasil
Hospital Instituto do Câncer Dr. Arnaldo Vieira de Carvalho
Eligibility
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients with head and neck cancer (CCP) histologically confirmed by biopsy and pathological anatomy, with weight loss above 5% in the last 12 months or body mass index (BMI) less than 20 kg/m²
Exclusion criteria
Exclusion criteria: Obesity (BMI equal or greater than 30kg/m²); preexisting inflammatory diseases; autoimmune diseases; chronic use of anti-inflammatory drugs and/or steroids; unbalanced diabetes mellitus; use of protein supplements; regular physical activity; use of probe for feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate whether leucine supplementation in patients with head and neck cancer can attenuate protein catabolism and weight loss, through densitometry and bioimpedance, as well as to evaluate the effect of supplementation on modulating the expression of inflammatory factors through the method of serum cytokine analysis. For verification, p less than 0.05 will be considered statistically significant and pre- and post-intervention parameters will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the nitrogen balance through the analysis of urinary urea and protein intake calculated by the food recall. To analyze the quality of life through questionnaires validated for the population. For verification, p less than 0.05 will be considered statistically significant and pre- and post-intervention parameters will be evaluated. | — |
Countries
Brazil
Contacts
Public ContactMárcia Santos
Universidade de São Paulo
Outcome results
None listed