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Age: 18Years +
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ID05384873

Study to Assess Immunonutrition Effects on Immunotherapy Success in Adults With Metastatic Non-Small Cell Lung Cancer

Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-05-01

180

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of oral nutritional supplements enriched with immunonutrients to improve the effectiveness of immunotherapy in patients with metastatic non-small cell lung cancer. The study focuses on patients undergoing first-line immunotherapy, with or without chemotherapy, and receiving nutritional counseling. The goal is to see if early provision of these specialized supplements can enhance treatment outcomes and patient well-being. Participants are randomly assigned to one of two groups. One group receives nutritional counseling plus two servings daily of a high-calorie, high-protein oral supplement enriched with immunonutrients called Oral Impact, starting about two weeks before cancer treatment and continuing for 12 to 14 weeks or longer as needed. The other group receives standard nutritional counseling with oral supplements provided only if food intake is insufficient, following usual clinical practice. During the study, patients will be monitored through regular assessments including progression-free survival over 12 months, response duration and overall survival up to 24 months, side effects for four months, and measures of muscle mass, fatigue, quality of life, and physical activity levels over 12 months. The study lasts at least until the first disease re-assessment and may continue longer based on patient needs and outcomes. Safety and treatment effects will be closely observed throughout.

CONDITIONS

Brief Title

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

Research Team

R

Riccardo Caccialanza, MD

A

Alessandra Ferrari, PharmD

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