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

Universidade Federal do Rio de Janeiro

Status: Enrolling

Conditions: Lung Cancer

Treatments: Drug: Placebo; Drug: Fish oil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04965129

40240420.2.0000.5533

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo Comparator: Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Experimental: Fish oil

Experimental group

Description:

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.

Treatment:

Drug: Fish oil