The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study

Riccardo Caccialanza; Emanuele Cereda; Catherine Klersy; Mariateresa Nardi; Sara Masi; Silvia Crotti; Silvia Cappello; Valentina Caissutti; Carlotta Brovia; Federica Lobascio; Elena Formisano; Sara Colombo; Andrea Riccardo Filippi; Elisabetta Bonzano; Patrizia Comoli; Laura Catenacci; Andrea Alberti; Valeria Musella; Alessandra Ferrari; Ilaria Imarisio; Richard Tancredi; Teresa Monaco; Maria Grazia Ghi; Paolo Bossi; Paolo Pedrazzoli

doi:10.1177/17588359211025872

The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study

Riccardo Caccialanza, Emanuele Cereda, Catherine Klersy, Mariateresa Nardi, Sara Masi, Silvia Crotti, Silvia Cappello, Valentina Caissutti, Carlotta Brovia, Federica Lobascio, Elena Formisano, Sara Colombo, Andrea Riccardo Filippi, Elisabetta Bonzano, Patrizia Comoli, Laura Catenacci, Andrea Alberti, Valeria Musella, Alessandra Ferrari, Ilaria ImarisioRichard Tancredi, Teresa Monaco, Maria Grazia Ghi, Paolo Bossi, Paolo Pedrazzoli

Research output: Contribution to journal › Article › peer-review

Abstract

Background: Nutritional support, including nutritional counseling and oral nutritional supplements (ONSs), has been recommended at the earliest opportunity in head and neck (H&N) cancer patients. The limited available evidence on the efficacy of immunonutrition during chemoradiotherapy (CT-RT) in H&N cancer patients is positive with regard to some secondary endpoints, but is still scanty, particularly with regard to toxicity and treatment tolerance. We hypothesize that early systematic provision of ONSs with a high-protein-high-calorie mixture containing immunonutrients (Impact) compared to standard high-calorie-high-protein nutritional blends, in addition to nutritional counseling, may be beneficial to patients with H&N cancer during CT-RT. Hence, we designed the present study to evaluate the efficacy, in terms of treatment tolerance, toxicity and response, body weight, body composition, protein-calorie intake, quality of life (QoL), fatigue, muscle strength and immunological profile of the early systematic provision of ONSs enriched in immunonutrients compared to isonitrogenous standard blends, in H&N cancer patients undergoing CT-RT.

Methods: This is a pragmatic, bicentric, randomized (1:1), parallel-group, open label, controlled, pilot clinical trial.

Discussion: Many efforts are still to be taken to improve the efficacy of nutritional support in oncology. Immunonutrition represents a promising approach also in H&N cancer patients, but the evidence on its efficacy in improving clinical outcomes during CT-RT is still inconclusive. The present pilot study, which guarantees the early provision of nutritional assessment and support to all the enrolled patients in accordance with the recent guidelines and recommendations, could represent one of the first proofs of the clinical effectiveness of early oral immunonutrition in cancer patients undergoing CT-RT and could stimulate further large randomized trials, potentially resulting in the improvement of supportive care quality.

Trial registration: This study is registered on ClinicalTrials.gov Identifier: NCT04611113.

Original language	English
Article number	17588359211025872
Pages (from-to)	1-13
Number of pages	13
Journal	Therapeutic advances in medical oncology
Volume	13
DOIs	https://doi.org/10.1177/17588359211025872
Publication status	Published - Sept 11 2021

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Caccialanza, R., Cereda, E., Klersy, C., Nardi, M., Masi, S., Crotti, S., Cappello, S., Caissutti, V., Brovia, C., Lobascio, F., Formisano, E., Colombo, S., Filippi, A. R., Bonzano, E., Comoli, P., Catenacci, L., Alberti, A., Musella, V., Ferrari, A., ... Pedrazzoli, P. (2021). The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study. Therapeutic advances in medical oncology, 13, 1-13. [17588359211025872]. https://doi.org/10.1177/17588359211025872

The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study. / Caccialanza, Riccardo ; Cereda, Emanuele ; Klersy, Catherine et al.

In: Therapeutic advances in medical oncology, Vol. 13, 17588359211025872, 11.09.2021, p. 1-13.

Research output: Contribution to journal › Article › peer-review

Caccialanza, R , Cereda, E , Klersy, C , Nardi, M, Masi, S, Crotti, S, Cappello, S , Caissutti, V, Brovia, C, Lobascio, F, Formisano, E, Colombo, S , Filippi, AR , Bonzano, E , Comoli, P , Catenacci, L, Alberti, A, Musella, V, Ferrari, A, Imarisio, I , Tancredi, R, Monaco, T, Ghi, MG, Bossi, P & Pedrazzoli, P 2021, 'The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study', Therapeutic advances in medical oncology, vol. 13, 17588359211025872, pp. 1-13. https://doi.org/10.1177/17588359211025872

Caccialanza R , Cereda E , Klersy C , Nardi M, Masi S, Crotti S et al. The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study. Therapeutic advances in medical oncology. 2021 Sept 11;13:1-13. 17588359211025872. doi: 10.1177/17588359211025872

Caccialanza, Riccardo ; Cereda, Emanuele ; Klersy, Catherine et al. / The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study. In: Therapeutic advances in medical oncology. 2021 ; Vol. 13. pp. 1-13.

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abstract = "Background: Nutritional support, including nutritional counseling and oral nutritional supplements (ONSs), has been recommended at the earliest opportunity in head and neck (H&N) cancer patients. The limited available evidence on the efficacy of immunonutrition during chemoradiotherapy (CT-RT) in H&N cancer patients is positive with regard to some secondary endpoints, but is still scanty, particularly with regard to toxicity and treatment tolerance. We hypothesize that early systematic provision of ONSs with a high-protein-high-calorie mixture containing immunonutrients (Impact) compared to standard high-calorie-high-protein nutritional blends, in addition to nutritional counseling, may be beneficial to patients with H&N cancer during CT-RT. Hence, we designed the present study to evaluate the efficacy, in terms of treatment tolerance, toxicity and response, body weight, body composition, protein-calorie intake, quality of life (QoL), fatigue, muscle strength and immunological profile of the early systematic provision of ONSs enriched in immunonutrients compared to isonitrogenous standard blends, in H&N cancer patients undergoing CT-RT.Methods: This is a pragmatic, bicentric, randomized (1:1), parallel-group, open label, controlled, pilot clinical trial.Discussion: Many efforts are still to be taken to improve the efficacy of nutritional support in oncology. Immunonutrition represents a promising approach also in H&N cancer patients, but the evidence on its efficacy in improving clinical outcomes during CT-RT is still inconclusive. The present pilot study, which guarantees the early provision of nutritional assessment and support to all the enrolled patients in accordance with the recent guidelines and recommendations, could represent one of the first proofs of the clinical effectiveness of early oral immunonutrition in cancer patients undergoing CT-RT and could stimulate further large randomized trials, potentially resulting in the improvement of supportive care quality.Trial registration: This study is registered on ClinicalTrials.gov Identifier: NCT04611113.",

author = "Riccardo Caccialanza and Emanuele Cereda and Catherine Klersy and Mariateresa Nardi and Sara Masi and Silvia Crotti and Silvia Cappello and Valentina Caissutti and Carlotta Brovia and Federica Lobascio and Elena Formisano and Sara Colombo and Filippi, {Andrea Riccardo} and Elisabetta Bonzano and Patrizia Comoli and Laura Catenacci and Andrea Alberti and Valeria Musella and Alessandra Ferrari and Ilaria Imarisio and Richard Tancredi and Teresa Monaco and Ghi, {Maria Grazia} and Paolo Bossi and Paolo Pedrazzoli",

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T1 - The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study

AU - Caccialanza, Riccardo

AU - Cereda, Emanuele

AU - Klersy, Catherine

AU - Nardi, Mariateresa

AU - Masi, Sara

AU - Crotti, Silvia

AU - Cappello, Silvia

AU - Caissutti, Valentina

AU - Brovia, Carlotta

AU - Lobascio, Federica

AU - Formisano, Elena

AU - Colombo, Sara

AU - Filippi, Andrea Riccardo

AU - Bonzano, Elisabetta

AU - Comoli, Patrizia

AU - Catenacci, Laura

AU - Alberti, Andrea

AU - Musella, Valeria

AU - Ferrari, Alessandra

AU - Imarisio, Ilaria

AU - Tancredi, Richard

AU - Monaco, Teresa

AU - Ghi, Maria Grazia

AU - Bossi, Paolo

AU - Pedrazzoli, Paolo

PY - 2021/9/11

Y1 - 2021/9/11

N2 - Background: Nutritional support, including nutritional counseling and oral nutritional supplements (ONSs), has been recommended at the earliest opportunity in head and neck (H&N) cancer patients. The limited available evidence on the efficacy of immunonutrition during chemoradiotherapy (CT-RT) in H&N cancer patients is positive with regard to some secondary endpoints, but is still scanty, particularly with regard to toxicity and treatment tolerance. We hypothesize that early systematic provision of ONSs with a high-protein-high-calorie mixture containing immunonutrients (Impact) compared to standard high-calorie-high-protein nutritional blends, in addition to nutritional counseling, may be beneficial to patients with H&N cancer during CT-RT. Hence, we designed the present study to evaluate the efficacy, in terms of treatment tolerance, toxicity and response, body weight, body composition, protein-calorie intake, quality of life (QoL), fatigue, muscle strength and immunological profile of the early systematic provision of ONSs enriched in immunonutrients compared to isonitrogenous standard blends, in H&N cancer patients undergoing CT-RT.Methods: This is a pragmatic, bicentric, randomized (1:1), parallel-group, open label, controlled, pilot clinical trial.Discussion: Many efforts are still to be taken to improve the efficacy of nutritional support in oncology. Immunonutrition represents a promising approach also in H&N cancer patients, but the evidence on its efficacy in improving clinical outcomes during CT-RT is still inconclusive. The present pilot study, which guarantees the early provision of nutritional assessment and support to all the enrolled patients in accordance with the recent guidelines and recommendations, could represent one of the first proofs of the clinical effectiveness of early oral immunonutrition in cancer patients undergoing CT-RT and could stimulate further large randomized trials, potentially resulting in the improvement of supportive care quality.Trial registration: This study is registered on ClinicalTrials.gov Identifier: NCT04611113.

AB - Background: Nutritional support, including nutritional counseling and oral nutritional supplements (ONSs), has been recommended at the earliest opportunity in head and neck (H&N) cancer patients. The limited available evidence on the efficacy of immunonutrition during chemoradiotherapy (CT-RT) in H&N cancer patients is positive with regard to some secondary endpoints, but is still scanty, particularly with regard to toxicity and treatment tolerance. We hypothesize that early systematic provision of ONSs with a high-protein-high-calorie mixture containing immunonutrients (Impact) compared to standard high-calorie-high-protein nutritional blends, in addition to nutritional counseling, may be beneficial to patients with H&N cancer during CT-RT. Hence, we designed the present study to evaluate the efficacy, in terms of treatment tolerance, toxicity and response, body weight, body composition, protein-calorie intake, quality of life (QoL), fatigue, muscle strength and immunological profile of the early systematic provision of ONSs enriched in immunonutrients compared to isonitrogenous standard blends, in H&N cancer patients undergoing CT-RT.Methods: This is a pragmatic, bicentric, randomized (1:1), parallel-group, open label, controlled, pilot clinical trial.Discussion: Many efforts are still to be taken to improve the efficacy of nutritional support in oncology. Immunonutrition represents a promising approach also in H&N cancer patients, but the evidence on its efficacy in improving clinical outcomes during CT-RT is still inconclusive. The present pilot study, which guarantees the early provision of nutritional assessment and support to all the enrolled patients in accordance with the recent guidelines and recommendations, could represent one of the first proofs of the clinical effectiveness of early oral immunonutrition in cancer patients undergoing CT-RT and could stimulate further large randomized trials, potentially resulting in the improvement of supportive care quality.Trial registration: This study is registered on ClinicalTrials.gov Identifier: NCT04611113.

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