Optimizing muscle mass and function in advanced lung cancer patients: randomized, double-blind, placebo-controlled trial protocol using High Eicosapentaenoic acid and PROtein (HEPRO) to modulate epigenetics, reduce toxicity and improve gut microbiota
Abstract
Background: Lung cancer is strongly associated with malnutrition and detrimental changes in muscle mass (MM), which can lead to reduced quality of life and reduced tolerance to and efficacy of antineoplastic treatment. The loss of MM and myosteatosis (fat infiltration into muscle) have been linked to inflammation in cancer, and n-3 polyunsaturated fatty acids (PUFA) found in fish oil are known to modulate inflammatory response, lean mass, microbiota, and epigenetic mechanisms.
Methods: High Eicosapentaenoic acid and PROtein (HEPRO) is a randomized, double-blind, placebo-controlled clinical trial. A total of 50 patients over 20 years of age diagnosed with stage III or IV non-small cell lung cancer with an ECOG performance status of 0-2 who are eligible for systemic treatment will be included and randomized 1:1 into two treatment arms: four fish oil capsules containing 2,100 mg EPA and 924 mg DHA per day versus four placebo capsules containing 2,250 mg oleic acid per day for 4 months. All patients will be instructed to consume 1.5 g protein per kg body weight per day and receive protein supplementation if necessary. MM, myosteatosis, muscle function, handgrip strength, dietary assessment, toxicity, response to treatment, and survival will be assessed. Translational research includes membrane phospholipid composition, gut microbiota, inflammation, and miRNA. MicroRNA will be analyzed by quantitative real-time polymerase chain reaction, phospholipids, by gas chromatography, and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 50 participants or records.
Read the paper
Related studies
- eggNOG 5.0: a hierarchical, functionally and phylogenetically annotated orthology resource based on 5090 organisms and 2502 viruses
- Online Survival Analysis Software to Assess the Prognostic Value of Biomarkers Using Transcriptomic Data in Non-Small-Cell Lung Cancer
- OptiType: precision HLA typing from next-generation sequencing data
- Nicotinic Cholinergic System and COVID-19: In Silico Identification of an Interaction between SARS-CoV-2 and Nicotinic Receptors with Potential Therapeutic Targeting Implications
- Saccharomyces cerevisiae cells have three Omega class glutathione S-transferases acting as 1-Cys thiol transferases
- Hemolysis at low blood flow rates: in-vitro and in-silico evaluation of a centrifugal blood pump
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.