Supplementation of n-3 PUFA in the Modulation of Lean Mass in Patients With Lung Cancer Receiving a High-protein Diet

Lung Cancer Clinical Trial

Official title:

Effect of Supplementation of Poly-unsaturated n-3 Fatty Acids and High-protein Diet on Epigenetic Modulation of Muscle Mass, Dose-limiting Toxicity and Intestinal Microbiota in Patients With Lung Cancer Submitted to Treatment With Immunotherapy, Chemotherapy and Tyrosine Kinase Inhibitors.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04965129
• Other study ID #: 40240420.2.0000.5533
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: May 15, 2024

Study information

• Verified date: February 2023
• Source: Universidade Federal do Rio de Janeiro
• Contact: Wilza AF Peres, PhD
• Phone: 552139386432
• Email: wilza[@]nutricao.ufrj.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 15, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Placebo
Drug: Placebo olive oil pill manufactured to mimic fish oil. Other Names: • Placebo
• Fish 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.

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Institutos Madrileño de Estudios Avanzados IMDEA, Oncoclínicas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change/maintenance in overall skeletal muscle density.	To assess the change/maintenance in muscle density from baseline to week 16 using computed tomography (CT).	16 weeks
Secondary	Change in muscle mass	CT-derived changes in muscle mass ocurring from baseline to week 16	16 weeks
Secondary	Red blood cell omega-3 fatty acid concentrations (eicosapentaenoic [EPA] and docosahexaenoic acid [DHA]	Assessed by gas chromatography (GC)	16 weeks
Secondary	Muscle strenght	Hand grip strength test	16 weeks
Secondary	Change in fecal microbiome composition	alpha- and beta-diversity of 16S bacterial rDNA	16 weeks
Secondary	Change in levels of miRNA 133	Measure the plasma levels of miRNA 133 from baseline to week 16 by real-time PCR	16 weeks