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

Sponsor

Universidade Federal do Rio de Janeiro (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04965129

Collaborator

Institutos Madrileño de Estudios Avanzados IMDEA (Other), Oncoclínicas (Industry)

Enrollment

Location

Arms

27.4

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is conducted to test the hypothesis that patients with lung cancer undergoing immunotherapy 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: Placebo Drug: Fish oil	N/A

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 immunotherapy 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 133, food consumption, membrane phospholipid composition, composition of the intestinal microbiota, toxicity, response to antineoplastic treatment and survival.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Supplementation of n-3 Polyunsaturated Fatty Acids and a High Protein Diet on Modulation of Muscle Mass and Intestinal Microbiota in Patients With Lung Cancer Undergoing Treatment With Immunotherapeutic Agents

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Comparator: 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.	Drug: Placebo Drug: Placebo olive oil pill manufactured to mimic fish oil. Other Names: • Placebo
Experimental: Experimental: 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.	Drug: 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. Other Names: Vital Fish

Arm

Intervention/Treatment

Placebo Comparator: Placebo Comparator: 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.

Drug: Placebo

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

Experimental: Experimental: 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.

Drug: 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.

Other Names:

Vital Fish

Outcome Measures

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in muscle mass [16 weeks]
CT-derived changes in muscle mass ocurring from baseline to week 16
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of non-small cell lung cancer, both sexes, ECOG performance status (0-1), treatment virgin, eligible for immunotherapy.

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.