دورية أكاديمية
Restorabite™: Phase II trial of jaw stretching exercises using a novel device for patients with trismus following head and neck cancer.
| العنوان: | Restorabite™: Phase II trial of jaw stretching exercises using a novel device for patients with trismus following head and neck cancer. |
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| المؤلفون: | Charters E; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.; School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia., Cheng K; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.; Royal Prince Alfred Institute of Academic Surgery, Sydney Local Health District, Sydney, Australia., Dunn M; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia., Heng C; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia., Loy J; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia., Ricketts V; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia., Luo A; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia., Aung YM; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia., Lewin W; Arto Hardy Family Biomedical Innovation Hub, Chris O'Brien Lifehouse, Sydney, Australia., Howes D; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.; University of Sydney Dental School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia., Manzie T; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.; Sydney Medical School, Faculty of Medicine and Health Sciences, The University of Sydney, Sydney, Australia., Wan B; School of Aerospace, Mechanical and Mechatronic Engineering, Faculty of Engineering, The University of Sydney, Sydney, Australia., Clark J; Department of Head and Neck Surgery, Chris O'Brien Lifehouse, Sydney, Australia.; Royal Prince Alfred Institute of Academic Surgery, Sydney Local Health District, Sydney, Australia.; Sydney Medical School, Faculty of Medicine and Health Sciences, The University of Sydney, Sydney, Australia. |
| المصدر: | International journal of cancer [Int J Cancer] 2024 Aug 15; Vol. 155 (4), pp. 731-741. Date of Electronic Publication: 2024 Mar 31. |
| نوع المنشور: | Journal Article; Clinical Trial, Phase II |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley-Liss Country of Publication: United States NLM ID: 0042124 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-0215 (Electronic) Linking ISSN: 00207136 NLM ISO Abbreviation: Int J Cancer Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 1995- : New York, NY : Wiley-Liss Original Publication: 1966-1984 : Genève : International Union Against Cancer |
| مواضيع طبية MeSH: | Trismus*/etiology , Trismus*/therapy , Head and Neck Neoplasms*/complications , Head and Neck Neoplasms*/therapy, Humans ; Female ; Male ; Middle Aged ; Aged ; Adult ; Prospective Studies ; Muscle Stretching Exercises ; Jaw ; Treatment Outcome ; Aged, 80 and over ; Quality of Life ; Patient Reported Outcome Measures |
| مستخلص: | Patients treated for oral cancer, may experience restricted mouth opening (trismus). Barriers such as cost have limited the utilization of traditional jaw stretching devices, and consequently, patients experience problems with swallowing, oral care, communication, and cancer surveillance. The safety and efficacy of Restorabite™, a new device designed to overcome these barriers, is evaluated prospectively over 12 months. This phase II investigator-led trial included patients with chronic trismus underwent 10-weeks of trismus therapy using Restorabite™. Safety, adherence, changes in mouth opening, and patient-reported outcomes are presented. 114/120 participants with trismus completed the intervention, and 104 had their progress monitored for 12 months. Thirteen participants withdrew due to tumour recurrence. At the completion of the intervention, mouth opening improved by 10.4 mm (p < .001). This increased to 13.7 mm at 12 months (p < .001). Patient reported outcome all significantly improved and 47 participants were no longer classified as having trismus. There were no serious treatment related adverse events. In patients with trismus following head and neck cancer treatment, a 10-week programme of jaw stretching exercises using Restorbite™ safely improves mouth opening and associated quality of life outcomes with high adherence and the benefits are maintained for 12-months. (© 2024 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.) |
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| معلومات مُعتمدة: | CINSW 2020/2081 The Cancer Institute New South Wales; Sydney Local Health District; The Lang Walker Family Foundation; Arto Hardy Family; Royal Australasian College of Surgeons; Chris O'Brien Lifehouse Seed Funding Surfebruary; Australian and New Zealand Head and Neck Cancer Society |
| فهرسة مساهمة: | Keywords: dysphagia; head and neoplasm; patient reported outcome measure; speech pathology; trismus |
| تواريخ الأحداث: | Date Created: 20240401 Date Completed: 20240619 Latest Revision: 20240809 |
| رمز التحديث: | 20240812 |
| DOI: | 10.1002/ijc.34941 |
| PMID: | 38556848 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1097-0215 |
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| DOI: | 10.1002/ijc.34941 |