RecruitingNot ApplicableNCT05384873

Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer

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

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Enrollment

180 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Lung Cancer, Nonsmall Cell

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a specially designed, high-protein, immune-boosting nutrition plan called immunonutrition can enhance the effectiveness of immunotherapy in people with advanced non-small cell lung cancer (NSCLC). Good nutritional status has been shown to influence how well immune-based cancer treatments work. **You may be eligible if...** - You have confirmed metastatic non-small cell lung cancer - You are starting immunotherapy (alone or combined with chemotherapy) as your first-line treatment - You are 18 or older - You are able to eat and drink normally or with minor support **You may NOT be eligible if...** - You are already receiving tube feeding, IV nutrition, or another structured nutrition support program - You are unable to provide informed consent - You have severe allergies to ingredients in the nutritional supplement - You have medical conditions that completely prevent adequate nutritional intake 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

DIETARY_SUPPLEMENTImmunonutrition

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

OTHERControl dietary intervention

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.