Evidence map›Paper›PMID 36434615›Full record

Trial reportBMC cancer2022

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, Catherine Klersy, Amanda Casirati, Elisabetta Montagna, Simona Carnio, Silvia Novello, Michele Milella, Sara Pilotto and 4 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05384873 (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), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05384873 narecruitingnot on this mapstarted 2023, after this paper: background citation

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

TypeinterventionalSponsorFondazione IRCCS Policlinico San Matteo di PaviaRan2023 to 2027Enrolled180ConditionsLung Cancer, Nonsmall CellArmsImmunonutrition, Control dietary intervention
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 1 country.

Riccardo Caccialanza *Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Viale Golgi 19, 27100, Pavia, Italy. r.caccialanza@smatteo.pv.it.ORCID http://orcid.org/0000-0002-9379-3569
Emanuele CeredaClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Viale Golgi 19, 27100, Pavia, Italy.
Francesco AgustoniMedical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Catherine KlersyBiometry and Clinical Epidemiology Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Amanda CasiratiClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Viale Golgi 19, 27100, Pavia, Italy.
Elisabetta MontagnaClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Viale Golgi 19, 27100, Pavia, Italy.
Simona CarnioDepartment of Oncology, AOU San Luigi-Orbassano, University of Turin, Turin, Italy.
Silvia Novello *Department of Oncology, AOU San Luigi-Orbassano, University of Turin, Turin, Italy.
Michele Milella *Medical Oncology, Department of Medicine, University of Verona Hospital Trust, 37134, Verona, Italy.
Sara PilottoMedical Oncology, Department of Medicine, University of Verona Hospital Trust, 37134, Verona, Italy.
Ilaria TrestiniMedical Oncology, Department of Medicine, University of Verona Hospital Trust, 37134, Verona, Italy.
Lucio Buffoni *Medical Oncology Unit, Humanitas Gradenigo, Turin, Italy.
Alessandra FerrariMedical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Paolo Pedrazzoli *Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Policlinico San Matteo Fondazione · ITUniversity of Verona · ITUniversity of Turin · ITOspedale Humanitas Gradenigo · ITUniversity of Pavia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNutritional 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.

methodsThis 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 registrationThis study is registered on ClinicalTrials.gov Identifier: NCT05384873.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsCounselingDietary SupplementsHumansImmunotherapyPilot ProjectsQuality of LifeChemotherapyImmunonutritionMalnutritionNon-small cell lung cancerNutritional counselingTreatment tolerance

Identifiers

PMID36434615
PMCPMC9700895
OpenAlexW4310054477

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.