Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fish oil | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo Comparator: Placebo
- 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.
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Experimental: Fish oil
- 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.
- interventionNames
- Drug: Fish oil
Primary outcomes (1)
- measure
- Change in muscle mass
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available