Using fish oil to improve muscle mass in lung cancer patients on 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.
This study is testing if taking fish oil can help lung cancer patients on a high-protein diet gain muscle mass while they are receiving treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | Universidade Federal do Rio de Janeiro Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Rio de Janeiro, Rio de Janeiro) |
| Trial ID | NCT04965129 on ClinicalTrials.gov |
What this trial studies
This study investigates whether fish oil supplementation can enhance muscle mass and modify the intestinal microbiome in patients with lung cancer who are receiving immunotherapy, chemotherapy, and tyrosine kinase inhibitors while on a high-protein diet. Over a period of four months, fifty participants will be randomly assigned to receive either fish oil or a placebo. The study will assess various factors including lean mass, inflammation, and the composition of the intestinal microbiota, aiming to understand the potential benefits of n-3 polyunsaturated fatty acids in this patient population.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with non-small cell lung cancer who are eligible for immunotherapy, chemotherapy, and tyrosine kinase inhibitors.
Not a fit: Patients who have experienced significant weight loss, chronic liver or kidney disease, or other specified health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve muscle mass and therapeutic responses in lung cancer patients, potentially enhancing their overall treatment outcomes.
How similar studies have performed: While the specific combination of fish oil supplementation and lung cancer treatment is novel, previous studies have shown positive effects of n-3 PUFA on inflammation and muscle mass in cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rio de Janeiro, Rio de Janeiro
- Federal University of Rio de Janeiro — Rio de Janeiro, Rio de Janeiro, Brazil (Recruiting)
Study contacts
- Principal investigator: Wilza AF Peres, PhD — Post-graduation in Nutrition, Institute of Nutrition
- Study coordinator: Wilza AF Peres, PhD
- Email: wilza@nutricao.ufrj.br
- Phone: 552139386432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.