Hanne Massonet1,2,3,4, Ann Goeleven5,6,7, Leen Van den Steen8,9, Alice Vergauwen9, Margot Baudelet10,11, Gilles Van Haesendonck9, Olivier Vanderveken9, Heleen Bollen12, Lisette van der Molen13,14, Fréderic Duprez10,11, Peter Tomassen15, Sandra Nuyts12, Gwen Van Nuffelen8,9,16. 1. Faculty of Medicine, Department of Neurosciences, Research Group Experimental Oto-Rhino-Laryngology - Delgutology, KU Leuven, Leuven, Belgium. hanne.massonet@kuleuven.be. 2. Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. hanne.massonet@kuleuven.be. 3. Department of Head and Neck Surgery, Swallowing Clinic, University Hospitals Leuven, Leuven, Belgium. hanne.massonet@kuleuven.be. 4. Department of ENT, Swallowing Clinic, University Hospitals Leuven, Leuven, Belgium. hanne.massonet@kuleuven.be. 5. Faculty of Medicine, Department of Neurosciences, Research Group Experimental Oto-Rhino-Laryngology - Delgutology, KU Leuven, Leuven, Belgium. 6. Department of Head and Neck Surgery, Swallowing Clinic, University Hospitals Leuven, Leuven, Belgium. 7. Department of ENT, Swallowing Clinic, University Hospitals Leuven, Leuven, Belgium. 8. Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium. 9. Department of Otolaryngology and Head and Neck Surgery, Rehabilitation Centre for Communication Disorders, Antwerp University Hospital, Antwerp, Belgium. 10. Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium. 11. Faculty of Medicine and Health Sciences, Department of Human Structure and Repair, Ghent University, Ghent, Belgium. 12. Department of Oncology, University Hospitals Leuven, Leuven, Belgium. 13. Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute, Amsterdam, The Netherlands. 14. Faculty of Humanities, University of Amsterdam, Amsterdam, The Netherlands. 15. Department of Head and Neck Surgery, Ghent University Hospital, Ghent, Belgium. 16. Faculty of Medicine and Health Sciences, Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium.
Abstract
BACKGROUND: Chronic radiation-associated dysphagia (C-RAD) is considered to be one of the most severe functional impairments in head and neck cancer survivors treated with radiation (RT) or chemoradiation (CRT). Given the major impact of these late toxicities on patients' health and quality of life, there is a strong need for evidence-based dysphagia management. Although studies report the benefit of strengthening exercises, transference of changes in muscle strength to changes in swallowing function often remains limited. Therefore, combining isolated strengthening exercises with functional training in patients with C-RAD may lead to greater functional gains. METHODS: This 3-arm multicenter randomized trial aims to compare the efficacy and possible detraining effects of mere strengthening exercises (group 1) with a combination of strengthening exercises and functional swallowing therapy (group 2) and non-invasive brain stimulation added to that combination (group 3) in 105 patients with C-RAD. Patients will be evaluated before and during therapy and 4 weeks after the last therapy session by means of swallowing-related and strength measures and quality of life questionnaires. DISCUSSION: Overall, this innovative RCT is expected to provide new insights into the rehabilitation of C-RAD to optimize post-treatment swallowing function. TRIAL REGISTRATION: International Standard Randomized Controlled Trials Number (ISRCTN) registry ID ISRCTN57028065. Registration was accepted on 15 July 2021.
BACKGROUND: Chronic radiation-associated dysphagia (C-RAD) is considered to be one of the most severe functional impairments in head and neck cancer survivors treated with radiation (RT) or chemoradiation (CRT). Given the major impact of these late toxicities on patients' health and quality of life, there is a strong need for evidence-based dysphagia management. Although studies report the benefit of strengthening exercises, transference of changes in muscle strength to changes in swallowing function often remains limited. Therefore, combining isolated strengthening exercises with functional training in patients with C-RAD may lead to greater functional gains. METHODS: This 3-arm multicenter randomized trial aims to compare the efficacy and possible detraining effects of mere strengthening exercises (group 1) with a combination of strengthening exercises and functional swallowing therapy (group 2) and non-invasive brain stimulation added to that combination (group 3) in 105 patients with C-RAD. Patients will be evaluated before and during therapy and 4 weeks after the last therapy session by means of swallowing-related and strength measures and quality of life questionnaires. DISCUSSION: Overall, this innovative RCT is expected to provide new insights into the rehabilitation of C-RAD to optimize post-treatment swallowing function. TRIAL REGISTRATION: International Standard Randomized Controlled Trials Number (ISRCTN) registry ID ISRCTN57028065. Registration was accepted on 15 July 2021.
Authors: Margot Baudelet; Leen Van den Steen; Peter Tomassen; Katrien Bonte; Philippe Deron; Wouter Huvenne; Sylvie Rottey; Wilfried De Neve; Nora Sundahl; Gwen Van Nuffelen; Fréderic Duprez Journal: Head Neck Date: 2019-07-22 Impact factor: 3.147
Authors: S A C Kraaijenga; I M Oskam; L van der Molen; O Hamming-Vrieze; F J M Hilgers; M W M van den Brekel Journal: Oral Oncol Date: 2015-05-28 Impact factor: 5.337
Authors: C L Lazarus; J A Logemann; B R Pauloski; A W Rademaker; C R Larson; B B Mittal; M Pierce Journal: J Speech Lang Hear Res Date: 2000-08 Impact factor: 2.297
Authors: Katherine A Hutcheson; Jan S Lewin; Denise A Barringer; Asher Lisec; G Brandon Gunn; Michael W S Moore; F Christopher Holsinger Journal: Cancer Date: 2012-05-17 Impact factor: 6.860
Authors: Herve Y Sroussi; Joel B Epstein; Rene-Jean Bensadoun; Deborah P Saunders; Rajesh V Lalla; Cesar A Migliorati; Natalie Heaivilin; Zachary S Zumsteg Journal: Cancer Med Date: 2017-10-25 Impact factor: 4.452