Emanuele Cereda1, Silvia Cappello1, Sara Colombo2, Catherine Klersy3, Ilaria Imarisio4, Annalisa Turri1, Marilisa Caraccia1, Valeria Borioli1, Teresa Monaco4, Marco Benazzo5, Paolo Pedrazzoli4, Franco Corbella2, Riccardo Caccialanza6. 1. Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 2. Division of Radiation Oncology, Department of Hemato-Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 3. Biometry and Statistics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 4. Division of Medical Oncology, Department of Hemato-Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 5. Department of Otolaryngology Head Neck Surgery, University of Pavia and Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 6. Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. Electronic address: r.caccialanza@smatteo.pv.it.
Abstract
BACKGROUND: To evaluate the benefit of oral nutritional supplements (ONS) in addition to nutritional counseling in head and neck cancer (HNC) patients undergoing radiotherapy (RT). METHODS: In a single-center, randomized, pragmatic, parallel-group controlled trial (ClinicalTrials.gov: NCT02055833; February 2014-August 2016), 159 newly diagnosed HNC patients suitable for to RT regardless of previous surgery and induction chemotherapy were randomly assigned to nutritional counseling in combination with ONS (N = 78) or without ONS (N = 81) from the start of RT and continuing for up to 3 months after its end. Primary endpoint was the change in body weight at the end of RT. Secondary endpoints included changes in protein-calorie intake, muscle strength, phase angle and quality of life and anti-cancer treatment tolerance. RESULTS: In patients with the primary endpoint assessed (modified intention-to-treat population), counseling plus ONS (N = 67) resulted in smaller loss of body weight than nutritional counseling alone (N = 69; mean difference, 1.6 kg [95%CI, 0.5-2.7]; P = 0.006). Imputation of missing outcomes provided consistent findings. In the ONS-supplemented group, higher protein-calorie intake and improvement in quality of life over time were also observed (P < 0.001 for all). The use of ONS reduced the need for changes in scheduled anti-cancer treatments (i.e. for RT and/or systemic treatment dose reduction or complete suspension, HR=0.40 [95%CI, 0.18-0.91], P = 0.029). CONCLUSION: In HNC patients undergoing RT or RT plus systemic treatment, and receiving nutritional counseling, the use of ONS resulted in better weight maintenance, increased protein-calorie intake, improved quality of life and was associated with better anti-cancer treatment tolerance.
RCT Entities:
BACKGROUND: To evaluate the benefit of oral nutritional supplements (ONS) in addition to nutritional counseling in head and neck cancer (HNC) patients undergoing radiotherapy (RT). METHODS: In a single-center, randomized, pragmatic, parallel-group controlled trial (ClinicalTrials.gov: NCT02055833; February 2014-August 2016), 159 newly diagnosed HNC patients suitable for to RT regardless of previous surgery and induction chemotherapy were randomly assigned to nutritional counseling in combination with ONS (N = 78) or without ONS (N = 81) from the start of RT and continuing for up to 3 months after its end. Primary endpoint was the change in body weight at the end of RT. Secondary endpoints included changes in protein-calorie intake, muscle strength, phase angle and quality of life and anti-cancer treatment tolerance. RESULTS: In patients with the primary endpoint assessed (modified intention-to-treat population), counseling plus ONS (N = 67) resulted in smaller loss of body weight than nutritional counseling alone (N = 69; mean difference, 1.6 kg [95%CI, 0.5-2.7]; P = 0.006). Imputation of missing outcomes provided consistent findings. In the ONS-supplemented group, higher protein-calorie intake and improvement in quality of life over time were also observed (P < 0.001 for all). The use of ONS reduced the need for changes in scheduled anti-cancer treatments (i.e. for RT and/or systemic treatment dose reduction or complete suspension, HR=0.40 [95%CI, 0.18-0.91], P = 0.029). CONCLUSION: In HNC patients undergoing RT or RT plus systemic treatment, and receiving nutritional counseling, the use of ONS resulted in better weight maintenance, increased protein-calorie intake, improved quality of life and was associated with better anti-cancer treatment tolerance.
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Authors: Christine Baldwin; Marian Ae de van der Schueren; Hinke M Kruizenga; Christine Elizabeth Weekes Journal: Cochrane Database Syst Rev Date: 2021-12-21
Authors: Andrea P Marshall; Georgia Tobiano; Shelley Roberts; Elisabeth Isenring; Jasotha Sanmugarajah; Deborah Kiefer; Rachael Fulton; Hui Lin Cheng; Ki Fung To; Po Shan Ko; Yuk Fong Lam; Wang Lam; Alex Molassiotis Journal: BMC Nutr Date: 2020-07-21
Authors: Riccardo Caccialanza; Emanuele Cereda; Francesco De Lorenzo; Gabriella Farina; Paolo Pedrazzoli Journal: BMC Cancer Date: 2018-03-27 Impact factor: 4.430