Restorabite™: Phase II trial of jaw stretching exercises using a novel device for patients with trismus following head and neck cancer

• Published in: International journal of cancer 2024-08, Vol.155 (4), p.731-741
• Main Authors: Charters, Emma, Cheng, Kai, Dunn, Masako, Heng, Caleb, Loy, Jamie, Ricketts, Virginia, Luo, Aaron, Aung, Yee Mon, Lewin, Will, Howes, Dale, Manzie, Timothy, Wan, Boyang, Clark, Jonathan
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Cancer therapies; Clinical outcomes; Clinical trials; dysphagia; Exercise; Female; Head & neck cancer; Head and neck; Head and Neck Neoplasms - complications; Head and Neck Neoplasms - therapy; head and neoplasm; Humans; Jaw; Male; Middle Aged; Mouth; Muscle Stretching Exercises; Oral carcinoma; patient reported outcome measure; Patient Reported Outcome Measures; Patients; Prospective Studies; Quality of Life; speech pathology; Treatment Outcome; trismus; Trismus - etiology; Trismus - therapy
• ISSN: 0020-7136; 1097-0215; 1097-0215
• DOI: 10.1002/ijc.34941

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