RecruitingNot ApplicableNCT04965129

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

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.


Sponsor

Universidade Federal do Rio de Janeiro

Enrollment

50 participants

Start Date

Nov 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether omega-3 fatty acid supplements (fish oil) can help people with lung cancer maintain muscle mass while following a high-protein diet during cancer treatment. **You may be eligible if...** - You have been diagnosed with non-small cell lung cancer (NSCLC) - You are receiving immunotherapy, chemotherapy, or targeted therapy (tyrosine kinase inhibitors) - Your physical performance status is reasonable (ECOG 0–2, meaning you can care for yourself) **You may NOT be eligible if...** - You have taken omega-3 supplements in the past 6 months - You have lost more than 10% of your body weight in the past 6 months - You have chronic liver disease, pre-existing kidney disease, anorexia, uncontrolled diabetes, or dementia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

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NCT04965129


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