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
Abstract 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 p...
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| Format: | Article |
| Language: | English |
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BMC
2022-11-01
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| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12885-022-10296-x |
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| author | Riccardo Caccialanza Emanuele Cereda Francesco Agustoni Catherine Klersy Amanda Casirati Elisabetta Montagna Simona Carnio Silvia Novello Michele Milella Sara Pilotto Ilaria Trestini Lucio Buffoni Alessandra Ferrari Paolo Pedrazzoli |
| author_facet | Riccardo Caccialanza Emanuele Cereda Francesco Agustoni Catherine Klersy Amanda Casirati Elisabetta Montagna Simona Carnio Silvia Novello Michele Milella Sara Pilotto Ilaria Trestini Lucio Buffoni Alessandra Ferrari Paolo Pedrazzoli |
| author_sort | Riccardo Caccialanza |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-04-11T13:53:55Z |
| format | Article |
| id | doaj.art-9683b02c81fe40d698ce876eb13e4111 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-04-11T13:53:55Z |
| publishDate | 2022-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-9683b02c81fe40d698ce876eb13e41112022-12-22T04:20:24ZengBMCBMC Cancer1471-24072022-11-0122111010.1186/s12885-022-10296-xMulticentre, 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 counselingRiccardo Caccialanza0Emanuele Cereda1Francesco Agustoni2Catherine Klersy3Amanda Casirati4Elisabetta Montagna5Simona Carnio6Silvia Novello7Michele Milella8Sara Pilotto9Ilaria Trestini10Lucio Buffoni11Alessandra Ferrari12Paolo Pedrazzoli13Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San MatteoClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San MatteoMedical Oncology Unit, Fondazione IRCCS Policlinico San MatteoBiometry and Clinical Epidemiology Service, Fondazione IRCCS Policlinico San MatteoClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San MatteoClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San MatteoDepartment of Oncology, AOU San Luigi-Orbassano, University of TurinDepartment of Oncology, AOU San Luigi-Orbassano, University of TurinMedical Oncology, Department of Medicine, University of Verona Hospital TrustMedical Oncology, Department of Medicine, University of Verona Hospital TrustMedical Oncology, Department of Medicine, University of Verona Hospital TrustMedical Oncology Unit, Humanitas GradenigoMedical Oncology Unit, Fondazione IRCCS Policlinico San MatteoMedical Oncology Unit, Fondazione IRCCS Policlinico San MatteoAbstract 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.https://doi.org/10.1186/s12885-022-10296-xNon-small cell lung cancerImmunonutritionNutritional counselingMalnutritionChemotherapyTreatment tolerance |
| spellingShingle | Riccardo Caccialanza Emanuele Cereda Francesco Agustoni Catherine Klersy Amanda Casirati Elisabetta Montagna Simona Carnio Silvia Novello Michele Milella Sara Pilotto Ilaria Trestini Lucio Buffoni Alessandra Ferrari Paolo Pedrazzoli 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 BMC Cancer Non-small cell lung cancer Immunonutrition Nutritional counseling Malnutrition Chemotherapy Treatment tolerance |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Non-small cell lung cancer Immunonutrition Nutritional counseling Malnutrition Chemotherapy Treatment tolerance |
| url | https://doi.org/10.1186/s12885-022-10296-x |
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