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The effects of Phoniatric PREhabilitation in Head and Neck Cancer patients on Aspi-ration and Preservation of Swallowing (PREHAPS): Study protocol of a monocentric prospective randomized interventional outcome-blinded trial

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Title: The effects of Phoniatric PREhabilitation in Head and Neck Cancer patients on Aspi-ration and Preservation of Swallowing (PREHAPS): Study protocol of a monocentric prospective randomized interventional outcome-blinded trial
Authors: Kuenzel, Julian, Duerr, Stephan, Vester, Sarah, Zeman, Florian, Huppertz, Gunnar, Koller, Michael, Pfleger, Gerda, Woertgen, Annika, Salloum, Hazem, Klinkhammer-Schalke, Monika, Pukrop, Tobias, Kummer, Peter
Source: Trials
Trials, Vol 25, Iss 1, Pp 1-10 (2024)
Publisher Information: Research Square Platform LLC, 2024.
Publication Year: 2024
Subject Terms: ddc:610, Medicine (General), FEES, Squamous Cell Carcinoma of Head and Neck, 610 Medizin, Preoperative Exercise, Dysphagia, Randomized controlled trial, Study Protocol, Deglutition [MeSH], Humans [MeSH], Prospective Studies [MeSH], Swallowing, Phoniatrics, Aspiration, Prehabilitation, Head and Neck Neoplasms/surgery [MeSH], Squamous Cell Carcinoma of Head and Neck [MeSH], Randomized Controlled Trials as Topic [MeSH], Quality of life, Head and neck cancer, Quality of Life [MeSH], Deglutition Disorders/prevention, Deglutition Disorders/diagnosis [MeSH], Preoperative Exercise [MeSH], Deglutition Disorders/etiology [MeSH], Deglutition, 3. Good health, R5-920, Prehabilitation, Head and neck cancer, Swallowing, Dysphagia, Aspiration, FEES, Phoniatrics, Quality of life, Randomized controlled trial, Head and Neck Neoplasms, Quality of Life, Humans, Prospective Studies, Deglutition Disorders, Randomized Controlled Trials as Topic
Description: Background: Dysphagia, with its negative impact on life expectancy and quality of life, is a major side effect of head and neck squamous cell carcinoma (HNSCC). In a typical Head and Neck Cancer Center, more than half of patients are affected. Improving treatment, and ideally prevention respectively prehabilitation, therefore seems more than desirable. Methods: The study is planned as a monocentric, prospective, outcome-blinded, randomized interventional study comparing an advanced phoniatric-logopedic prehabilitation with a control (standard of care). Sixty patients (control group 30/intervention group 30) with an initial diagnosis of invasive HNSCC and curative treatment intention will be included over a period of 17 months. In addition to the previous standard, both groups will undergo both, detailed subjective assessment of swallowing function and quality of life by means of various questionnaires, as well as objective analyses by bioelectrical impedance measurements and phoniatric endoscopic swallowing examinations. In the intervention group, risk-related nutritional counseling (face-to-face) and phoniatric-logopedic prehabilitation are provided: Detailed counseling with video demonstration and exercises to strengthen and improve range of motion of the oral, pharyngeal, and laryngeal muscles (guided by exercise diary). Controls are performed 6 weeks, 3 and 6 months, as well as 9 or 12 months after the end of therapy during the regular tumor follow-up. Primary study endpoints are swallowing function and emotional distress at 6 weeks control visit. Discussion: Prehabilitation measures have already proven successful in other patient groups, e.g. transplant patients. In the field of head and neck oncology, interest in such concepts has increased significantly in recent years. However, usually only subgroups, e.g. patients with swallowing problems after radiochemotherapy alone, are in focus. Our study aims to investigate the general benefit of prehabilitation with regard to swallowing function, which is so important for protection of aspiration and quality of life. Trial registration: DRKS00029676 (German Clinical Trials Register https://drks.de/search/de/trial/DRKS00029676; International Clinical Trials Registry Platform https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00029676).
Document Type: Article
Other literature type
File Description: application/pdf
ISSN: 1745-6215
DOI: 10.21203/rs.3.rs-3554605/v1
DOI: 10.1186/s13063-024-08010-2
DOI: 10.5283/epub.57989
DOI: 10.1186/s13063-024-08010-210.5283/epub.57989
Access URL: https://pubmed.ncbi.nlm.nih.gov/38519961
https://doaj.org/article/75cecd90d8c8446a9da7dc0f747b5a2f
https://repository.publisso.de/resource/frl:6504489
https://epub.uni-regensburg.de/57989/
Rights: CC BY
URL: http://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (http://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (http://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Accession Number: edsair.doi.dedup.....93d96bf26e3bef6913fa7324c58ff771
Database: OpenAIRE
Description
Abstract:Background: Dysphagia, with its negative impact on life expectancy and quality of life, is a major side effect of head and neck squamous cell carcinoma (HNSCC). In a typical Head and Neck Cancer Center, more than half of patients are affected. Improving treatment, and ideally prevention respectively prehabilitation, therefore seems more than desirable. Methods: The study is planned as a monocentric, prospective, outcome-blinded, randomized interventional study comparing an advanced phoniatric-logopedic prehabilitation with a control (standard of care). Sixty patients (control group 30/intervention group 30) with an initial diagnosis of invasive HNSCC and curative treatment intention will be included over a period of 17 months. In addition to the previous standard, both groups will undergo both, detailed subjective assessment of swallowing function and quality of life by means of various questionnaires, as well as objective analyses by bioelectrical impedance measurements and phoniatric endoscopic swallowing examinations. In the intervention group, risk-related nutritional counseling (face-to-face) and phoniatric-logopedic prehabilitation are provided: Detailed counseling with video demonstration and exercises to strengthen and improve range of motion of the oral, pharyngeal, and laryngeal muscles (guided by exercise diary). Controls are performed 6 weeks, 3 and 6 months, as well as 9 or 12 months after the end of therapy during the regular tumor follow-up. Primary study endpoints are swallowing function and emotional distress at 6 weeks control visit. Discussion: Prehabilitation measures have already proven successful in other patient groups, e.g. transplant patients. In the field of head and neck oncology, interest in such concepts has increased significantly in recent years. However, usually only subgroups, e.g. patients with swallowing problems after radiochemotherapy alone, are in focus. Our study aims to investigate the general benefit of prehabilitation with regard to swallowing function, which is so important for protection of aspiration and quality of life. Trial registration: DRKS00029676 (German Clinical Trials Register https://drks.de/search/de/trial/DRKS00029676; International Clinical Trials Registry Platform https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00029676).
ISSN:17456215
DOI:10.21203/rs.3.rs-3554605/v1