Clinical trial

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.

Name

40240420.2.0000.5533

Description

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.

Trial arms

Trial start

2022-11-15

Estimated PCD

2024-05-01

Trial end

2025-03-15

Status

Recruiting

Treatment

Placebo

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

Arms:

Placebo Comparator: 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.

Arms:

Experimental: Fish oil

Other names:

Vital Fish

Size

Primary endpoint

Change in muscle mass

16 weeks

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-05-17

1 organization

1 product

1 drug

1 indication

Organization

Universidade Federal do Rio de Janeiro

Drug

Varlilumab

Indication

lung cancer

Product

Fish oil