Lung Cancer
Conditions
Keywords
fish oils, body composition, microbiota, epigenetics, lung cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGPlacebo
Drug: Placebo olive oil pill manufactured to mimic fish oil. Other Names: • Placebo
DRUGFish oil
All subjects will be given fish oil with a dose of of 2.100 mg of EPA and 924 mg of DHA, in four tablet twice daily for four mounths.
Sponsors
Institutos Madrileño de Estudios Avanzados IMDEA
Oncoclínicas
Universidade Federal do Rio de Janeiro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of non-small cell lung cancer, both sexes, ECOG performance status (0-2) eligible for treatment with immunotherapy, chemotherapy and tyrosine Kinase Inhibitors.
Exclusion criteria
* supplementation of PUFA n-3 in the last 6 months; weight loss\> 10% in 6 months, chronic liver disease, previous chronic kidney disease, anorexia, decompensated diabetes mellitus and dementia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle mass | 16 weeks | CT-derived changes in muscle mass ocurring from baseline to week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Red blood cell omega-3 fatty acid concentrations (eicosapentaenoic [EPA] and docosahexaenoic acid [DHA] | 16 weeks | Assessed by gas chromatography (GC) |
| Muscle strenght | 16 weeks | Hand grip strength test |
| Change in fecal microbiome composition | 16 weeks | alpha- and beta-diversity of 16S bacterial rDNA |
| Change in levels of miRNA 133 | 16 weeks | Measure the plasma levels of miRNA 133 from baseline to week 16 by real-time PCR |
| Change/maintenance in overall skeletal muscle density. | 16 weeks | To assess the change/maintenance in muscle density from baseline to week 16 using computed tomography (CT). |
Countries
Brazil
Contacts
Primary ContactWilza AF Peres, PhD
Backup ContactImanuely B Gonçalves, MsC
Outcome results
None listed