Home-based intensive treatment of chronic radiation-associated dysphagia in head and neck cancer survivors (HIT-CRAD trial)
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...
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| Format: | Article |
| Language: | English |
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BMC
2022-10-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06832-6 |
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| author | Hanne Massonet Ann Goeleven Leen Van den Steen Alice Vergauwen Margot Baudelet Gilles Van Haesendonck Olivier Vanderveken Heleen Bollen Lisette van der Molen Fréderic Duprez Peter Tomassen Sandra Nuyts Gwen Van Nuffelen |
| author_facet | Hanne Massonet Ann Goeleven Leen Van den Steen Alice Vergauwen Margot Baudelet Gilles Van Haesendonck Olivier Vanderveken Heleen Bollen Lisette van der Molen Fréderic Duprez Peter Tomassen Sandra Nuyts Gwen Van Nuffelen |
| author_sort | Hanne Massonet |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-12T15:54:41Z |
| format | Article |
| id | doaj.art-0ee344c602c148dab84f4e763e330acc |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T15:54:41Z |
| publishDate | 2022-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-0ee344c602c148dab84f4e763e330acc2022-12-22T03:26:24ZengBMCTrials1745-62152022-10-0123111510.1186/s13063-022-06832-6Home-based intensive treatment of chronic radiation-associated dysphagia in head and neck cancer survivors (HIT-CRAD trial)Hanne Massonet0Ann Goeleven1Leen Van den Steen2Alice Vergauwen3Margot Baudelet4Gilles Van Haesendonck5Olivier Vanderveken6Heleen Bollen7Lisette van der Molen8Fréderic Duprez9Peter Tomassen10Sandra Nuyts11Gwen Van Nuffelen12Faculty of Medicine, Department of Neurosciences, Research Group Experimental Oto-Rhino-Laryngology - Delgutology, KU LeuvenFaculty of Medicine, Department of Neurosciences, Research Group Experimental Oto-Rhino-Laryngology - Delgutology, KU LeuvenFaculty of Medicine and Health Sciences, University of AntwerpDepartment of Otolaryngology and Head and Neck Surgery, Rehabilitation Centre for Communication Disorders, Antwerp University HospitalDepartment of Radiation Oncology, Ghent University HospitalDepartment of Otolaryngology and Head and Neck Surgery, Rehabilitation Centre for Communication Disorders, Antwerp University HospitalDepartment of Otolaryngology and Head and Neck Surgery, Rehabilitation Centre for Communication Disorders, Antwerp University HospitalDepartment of Oncology, University Hospitals LeuvenDepartment of Head and Neck Oncology and Surgery, The Netherlands Cancer InstituteDepartment of Radiation Oncology, Ghent University HospitalDepartment of Head and Neck Surgery, Ghent University HospitalDepartment of Oncology, University Hospitals LeuvenFaculty of Medicine and Health Sciences, University of AntwerpAbstract 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.https://doi.org/10.1186/s13063-022-06832-6DysphagiaHead and neck cancerChemoradiotherapySwallowing exercisesTongue strengthening exercisesExpiratory Muscle Strength Training (EMST) |
| spellingShingle | Hanne Massonet Ann Goeleven Leen Van den Steen Alice Vergauwen Margot Baudelet Gilles Van Haesendonck Olivier Vanderveken Heleen Bollen Lisette van der Molen Fréderic Duprez Peter Tomassen Sandra Nuyts Gwen Van Nuffelen Home-based intensive treatment of chronic radiation-associated dysphagia in head and neck cancer survivors (HIT-CRAD trial) Trials Dysphagia Head and neck cancer Chemoradiotherapy Swallowing exercises Tongue strengthening exercises Expiratory Muscle Strength Training (EMST) |
| title | Home-based intensive treatment of chronic radiation-associated dysphagia in head and neck cancer survivors (HIT-CRAD trial) |
| title_full | Home-based intensive treatment of chronic radiation-associated dysphagia in head and neck cancer survivors (HIT-CRAD trial) |
| title_fullStr | Home-based intensive treatment of chronic radiation-associated dysphagia in head and neck cancer survivors (HIT-CRAD trial) |
| title_full_unstemmed | Home-based intensive treatment of chronic radiation-associated dysphagia in head and neck cancer survivors (HIT-CRAD trial) |
| title_short | Home-based intensive treatment of chronic radiation-associated dysphagia in head and neck cancer survivors (HIT-CRAD trial) |
| title_sort | home based intensive treatment of chronic radiation associated dysphagia in head and neck cancer survivors hit crad trial |
| topic | Dysphagia Head and neck cancer Chemoradiotherapy Swallowing exercises Tongue strengthening exercises Expiratory Muscle Strength Training (EMST) |
| url | https://doi.org/10.1186/s13063-022-06832-6 |
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