At a glance
ClinicalIndex Comparison Record- ✓Confirmed histological diagnosis of metastatic non-small cell lung cancer
- ✓First-line treatment with immunotherapy alone or in combination with chemotherapy for metastatic disease
- ✓Written informed consent required
- ✓Ability to administer oral supplements and immunotherapy with or without chemotherapy
- ✕Age <18 years
- ✕Inability to sign informed consent
- ✕Indication to or ongoing artificial nutrition support or incapacity to consume oral nutritional supplements
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicentre, Randomised, Open-label, Parallel-group Trial to Evaluate Immunonutrition in Improving Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer, Undergoing Systematic Nutritional Counseling
In Brief
A clinical study evaluating Immunonutrition and Control dietary intervention for Lung Cancer, Nonsmall Cell. Currently recruiting, targeting 180 participants across 1 site.
Detailed Summary
The present study was designed to evaluate the efficacy of the early systematic provision of oral nutritional supplements enriched in immunonutrients in non-small lung cancer patients undergoing immunotherapy and receiving nutritional counseling
Study Details
Timeline
Interventions
In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients (Oral Impact®). The intervention will start approximately two weeks before anticancer treatment initiation and will continue up to first disease re-assessment (12-14 weeks) and prolonged according to patient's needs
Patients will receive nutritional counseling as standard of care. Nutritional counseling may comprise the use of oral nutritional supplements (ONS), which are usually prescribed when patients are unable to maintain satisfactory spontaneous food intake (less than 50% of the requirement for more than one week or only 50-75% of the requirement for more than two weeks). Therefore, in this arm the use of isonitrogenous standard blend ONS will be considered according to the regular assessment of food intake.