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

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Drug: Placebo; Drug: Fish oil

• Registration Number: NCT04965129
• Lead Sponsor: Universidade Federal do Rio de Janeiro

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.

Study Timeline

• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-16
• Study Start: 2022-11-15
• Status Verified: 2024-05
• Primary Completion: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator: Placebo	Placebo	Placebo Comparator: Placebo All subjects will be given placebo identically matched with regard to shape, color and taste. They will be given four tablet/day for four mounths.
Experimental: Fish oil	Fish oil	All subjects will be given fish oil with a dose of 2.100 mg of EPA and 924 mg of DHA, in four tablet twice daily for four mounths.

Primary Outcome Measures

Name	Time	Method
Change in muscle mass	16 weeks	CT-derived changes in muscle mass ocurring from baseline to week 16

Secondary Outcome Measures

Name	Time	Method
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 in fecal microbiome composition	16 weeks	alpha- and beta-diversity of 16S bacterial rDNA
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/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).

Trial Locations

Locations (1)

Federal University of Rio de Janeiro; 🇧🇷 Rio de Janeiro, RJ, Brazil