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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Confirmed histological diagnosis of metastatic non-small cell lung cancer (both squamous and non-squamous histology)
First-line treatment with immunotherapy alone or with chemotherapy for metastatic disease
Willingness to participate and provide written informed consent
Ability to take oral supplements and receive immunotherapy with or without chemotherapy
Eastern Cooperative Oncology Group Performance Status of 2 or less
Life expectancy of 6 months or more
You will not qualify if you...
Age under 18 years
Unable to sign informed consent
Need for or currently receiving artificial nutrition support due to completely compromised spontaneous food intake
Unable or unwilling to consume oral nutritional supplements
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 12 to 14 weeks or longer depending on participant's needs
Participants receive nutritional counseling and may take oral nutritional supplements. Those in the immunonutrition group will start taking two servings of a high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients approximately two weeks before starting anticancer treatment and continue up to the first disease re-assessment (12-14 weeks). The duration may be prolonged based on participant needs.
Regular visits for treatment and nutritional assessment during this period
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Multicentre, randomised, open-label, parallel-group, clinical phase II study to evaluate immunonutrition in improving efficacy of immunotherapy in patients with metastatic non-small cell lung cancer, undergoing systematic nutritional counseling.
Riccardo Caccialanza, Emanuele Cereda, Francesco Agustoni...