Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA.
Center for Immunotherapy and Precision Immuno-Oncology, Cleveland Clinic Lerner Research Institute, Cleveland, OH, USA.
Ann Otol Rhinol Laryngol. 2024 Nov;133(11):979-983. doi: 10.1177/00034894241275463. Epub 2024 Aug 19.
Head and neck cancer (HNC) patients often have dysphagia following surgical and/or chemoradiation treatment, which can lead to reduced quality of life. Some patients suffer from decreased tongue strength and mobility that may cause discomfort and difficulty with swallowing. Our group has developed a patented genioglossus muscle strength trainer (GMST) to increase tongue protrusive force that has been used in patients with sleep apnea. We hypothesized that the GMST device would increase tongue strength in the HNC population.
We conducted an IRB approved, non-randomized, interventional clinical trial of HNC patients with dysphagia to determine the effect of GMST on tongue strength. Our secondary objective was to assess dysphagia quality of life, as determined by questionnaires. Genioglossus muscle strength measurements (measured in Newtons, N) and dysphagia quality of life scores (SWAL-QoL questionnaire) were obtained from enrolled patients at baseline and following 4 weeks of intervention. Treatment was at-home GMST exercise regimen 3 times daily, 5 days per week. Compliance was assessed via review of training logs. Two-sided paired -tests at significance level α = .05 were performed to assess difference in mean GG muscle strength pre- and post-treatment.
Out of 10 patients initially enrolled, 7 patients completed the trial. Eighty-six percent were male and the average age was 60. About 5 patients had surgery plus adjuvant radiation and 2 patients had primary radiation. All patients had baseline dysphagia as determined by patient complaint and/or objective measurement (prior modified barium swallow). No adverse events were reported. We observed a statistically significant increase in genioglossus muscle strength (mean change: 4.0 N, 95% CI 1.1-6.9, = .015) after 4 weeks of treatment. Patients reported reduced swallowing burden and feeling of stigma around eating based on SWAL-QoL results.
Our data suggest that protrusive tongue-training exercises utilizing a novel tongue trainer device is well-tolerated and increases genioglossus muscle strength in treated HNC patients complaining of dysphagia. Patient-reported outcomes based on the SWAL-QoL survey indicate improvements in quality-of-life post-treatment, although our results are limited by small sample size. Larger studies are needed to see if this device could have clinically meaningful results for this difficult-to-treat patient population.
头颈部癌症(HNC)患者在接受手术和/或放化疗后常出现吞咽困难,这会导致生活质量下降。一些患者会出现舌肌无力和运动受限的情况,这可能会导致不适和吞咽困难。我们的团队开发了一种专利的颏舌肌力量训练器(GMST),用于增加舌突出力,该训练器已用于治疗睡眠呼吸暂停患者。我们假设 GMST 装置会增加 HNC 人群的舌力。
我们进行了一项经过机构审查委员会(IRB)批准的、非随机的、干预性临床试验,纳入了吞咽困难的 HNC 患者,以确定 GMST 对舌力的影响。我们的次要目标是通过问卷调查评估吞咽困难的生活质量。在基线和干预 4 周后,从入组患者中获得颏舌肌力量测量值(以牛顿为单位,N)和吞咽困难生活质量评分(SWAL-QoL 问卷)。治疗是在家中每天进行 3 次 GMST 运动,每周 5 天。通过审查训练日志来评估依从性。采用双侧配对 t 检验,显著性水平α=0.05,评估治疗前后 GG 肌肉力量的平均值差异。
最初入组的 10 名患者中,有 7 名患者完成了试验。86%为男性,平均年龄为 60 岁。约有 5 名患者接受了手术加辅助放疗,2 名患者接受了单纯放疗。所有患者均有吞咽困难,通过患者自述和/或客观测量(先前改良的钡吞咽)确定。无不良事件报告。我们观察到,经过 4 周的治疗,颏舌肌力量有显著增加(平均变化:4.0N,95%置信区间 1.1-6.9,P=0.015)。根据 SWAL-QoL 结果,患者报告吞咽负担减轻,进食时的耻辱感减轻。
我们的数据表明,使用新型舌训练器进行突出舌训练运动在吞咽困难的 HNC 患者中耐受性良好,并可增加颏舌肌力量。基于 SWAL-QoL 调查的患者报告结果表明,治疗后生活质量有所改善,尽管我们的结果受到样本量小的限制。需要更大的研究来确定该设备是否能为这一难以治疗的患者群体带来有临床意义的结果。