Using immunonutrition to enhance immunotherapy effectiveness in lung cancer patients
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
This study tests if giving special nutritional supplements to lung cancer patients receiving immunotherapy can help their treatment work better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Pavia) |
| Trial ID | NCT05384873 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of early systematic provision of oral nutritional supplements enriched with immunonutrients for patients with metastatic non-small cell lung cancer who are undergoing immunotherapy. Participants will receive nutritional counseling alongside their treatment to assess whether this approach improves treatment efficacy. The study aims to provide insights into the role of nutrition in cancer therapy, particularly in enhancing the immune response during treatment.
Who should consider this trial
Good fit: Ideal candidates include adults with a confirmed diagnosis of metastatic non-small cell lung cancer who are starting first-line immunotherapy.
Not a fit: Patients under 18 years old or those requiring artificial nutrition support will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the effectiveness of immunotherapy in lung cancer patients, potentially leading to better treatment outcomes.
How similar studies have performed: While the specific combination of immunonutrition and immunotherapy is novel, similar studies exploring nutritional interventions in cancer treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed histological diagnosis of metastatic non-small cell lung cancer (both squamous and non-squamous histology); * First-line treatment with immunotherapy (alone or in combination with chemotherapy) for metastatic disease by investigators' choice within the framework of good clinical practice and in agreement with current guidelines; * Will to participate by providing written informed consent; * Availability to administer oral supplements and immunotherapy with or without chemotherapy; * Eastern Cooperative Oncology Group Performance Status ≤ 2; * Life expectancy ≥ 6 months. Exclusion Criteria: * Age \< 18 years; * Inability to sign an informed consent; * Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume oral nutritional supplements
Where this trial is running
Pavia
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
Study contacts
- Principal investigator: Riccardo Caccialanza, MD — Fondazione IRCCS Policlinico San Matteo
- Study coordinator: Riccardo Caccialanza, MD
- Email: r.caccialanza@smatteo.pv.it
- Phone: 0382501615
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.