Journal Article

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

Montagna, Elisabetta, Pilotto, Sara, Pedrazzoli, Paolo, Klersy, Catherine, Milella, Michele, Ferrari, Alessandra, Carnio, Simona, Caccialanza, Riccardo, Novello, Silvia, Buffoni, Lucio, Cereda, Emanuele, Trestini, Ilaria, Agustoni, Francesco, Casirati, Amanda

2022

Overview

Background Nutritional support, including nutritional counseling and oral nutritional supplements (ONS), has been recommended as a first-line strategy in patients with non-small cell lung cancer (NSCLC). Evidence on the efficacy of immunonutrition during immunotherapy in these patients is positive, but still limited some secondary endpoints, such as treatment toxicity and tolerance. We hypothesize that early systematic provision of ONS with a high-protein-high calorie mixture containing immunonutrients (Impact®) in addition to nutritional counseling, compared to nutritional counseling alone, is beneficial to patients with NSCLC receiving immunotherapy with or without chemotherapy. We designed the present study to evaluate the efficacy of early systematic provision of ONS enriched with immunonutrients compared to nutritional counseling alone, in patients with NSCLC undergoing immunotherapy. Study endpoints were: treatment response (primary endpoint: progression-free survival), treatment tolerance and toxicity, body weight, body composition, protein-calorie intake, quality of life, fatigue, muscle strength and immunological profile. Methods This is a pragmatic, multicentre, randomized (1:1), parallel-group, open label, controlled, pilot clinical trial ( N  = 180). Discussion The improvement of efficacy of nutritional support in oncology still deserves many efforts. Immunonutrition represents a promising approach also in patients with NSCLC, but evidence on its efficacy on clinical outcomes during immunotherapy is still inconclusive. The present pilot study, which guarantees early high-quality nutritional care (assessment and treatment) to all patients in agreement with current guidelines and recommendations, could represent one of the first proofs of efficacy of early oral immunonutrition in patients with cancer undergoing immunotherapy. Further large randomized trials addressing the improvement of supportive care could be hypothesized, accordingly. Trial registration This study is registered on ClinicalTrials.gov Identifier: NCT05384873.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Abdomen / Biomedical and Life Sciences / Biomedicine / Body composition / Body mass index / Body weight / Calories / Cancer / Cancer Research / Cancer therapies / Carcinoma, Non-Small-Cell Lung - therapy / Care and treatment / Chemotherapy / Clinical medicine / Clinical trials / Counseling / Diet therapy / Dietary Supplements / Exercise / Fatty acids / Food / Health aspects / Health Promotion and Disease Prevention / Histology / Humans / Immune system / Immunological tolerance / Immunonutrition / Immunotherapy / Informed consent / Lung cancer / Lung cancer, Non-small cell / Lung Neoplasms - therapy / Malnutrition / Management / Medical prognosis / Medicine/Public Health / Metastases / Metastasis / Muscle strength / Non-small cell lung cancer / Non-small cell lung carcinoma / Nutrition counseling / Nutritional counseling / Oncology / Patients / Physical fitness / Physiological aspects / Pilot Projects / Protein composition / Proteins / Quality of Life / Questionnaires / Small cell lung carcinoma / Software / Study Protocol / Surgical Oncology / Testing / Toxicity tolerance / Treatment tolerance