This study is conducted to test the hypothesis that patients with lung cancer undergoing treatment with immunotherapy, chemotherapy and tyrosine Kinase Inhibitors receiving a high protein diet and supplemented with fish oil will improve muscle mass, therapeutic response and modulate the intestinal microbiota within a 4 month period.
Lung cancer (PC) is the most prevalent tumor. The loss of muscle mass, myosteatosis and changes in body composition have been associated with inflammation in cancer and PUFA n-3 have been shown to be an important modulator of the inflammatory response and epigenetic mechanisms. Additionally, the intestinal microbiome has received prominence with the use of immunotherapy, as it is demonstrating that resistance to this therapy can be attributed to the abnormal composition of the intestinal microbiome. Aims: The purpose of this study is to assess the effects of fish oil supplementation in the modulation of lean mass and intestinal microbiome in patients with lung cancer undergoing treatment with immunotherapy, chemotherapy and Tyrosine Kinase Inhibitors receiving a high-protein diet. Methods: Fifty patients will be randomly allocated either to treatment with fish oil or to placebo for 4 months. The following assessments will be made: lean mass, myosteatosis, sarcopenia, adipose compartment, inflammation, micro RNA, food consumption, membrane phospholipid composition, composition of the intestinal microbiota, toxicity, response to antineoplastic treatment and survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
RECRUITINGChange in muscle mass
CT-derived changes in muscle mass ocurring from baseline to week 16
Time frame: 16 weeks
Red blood cell omega-3 fatty acid concentrations (eicosapentaenoic [EPA] and docosahexaenoic acid [DHA]
Assessed by gas chromatography (GC)
Time frame: 16 weeks
Muscle strenght
Hand grip strength test
Time frame: 16 weeks
Change in fecal microbiome composition
alpha- and beta-diversity of 16S bacterial rDNA
Time frame: 16 weeks
Change in levels of miRNA 133
Measure the plasma levels of miRNA 133 from baseline to week 16 by real-time PCR
Time frame: 16 weeks
Change/maintenance in overall skeletal muscle density.
To assess the change/maintenance in muscle density from baseline to week 16 using computed tomography (CT).
Time frame: 16 weeks
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