METHODS: This was a single-center randomized self-controlled clinical trial. At CT simulation, an open-face and closed mask was made for each patient and treatment plans with identical dose prescription were generated for each mask. Patients were randomised to start treatment with an open-face or closed mask. Masks were switched halfway through the treatment course; every patient was their own control. Patients self-reported discomfort, anxiety and pain using the visual analogue scale (VAS). Inter- and intrafraction set-up variability was measured with planar kV imaging and a surface guided radiotherapy (SGRT) system for the open-face masks.
RESULTS: 30 patients with primary or metastatic brain tumors were randomized - 29 completed radiotherapy to a median total dose of 54 Gy (range 30-60 Gy). Mean discomfort VAS score was significantly lower with open-face masks (0.5, standard deviation 1.0) vs. closed masks (3.3, standard deviation 2.9), P < 0.0001. Anxiety and pain VAS scores were significantly lower with open-face masks (P < 0.0001). Closed masks caused more discomfort in infraorbital (P < 0.001) and maxillary (P = 0.02) areas. Two patients and 27 patients preferred closed or open-face masks, respectively. Interfraction longitudinal shifts and roll and yaw rotations were significantly smaller and lateral shifts were significantly larger with closed masks in combination with the laser system (P < 0.05) compared to open masks in combination with a SGRT system. Intrafraction variability did not differ between the masks.
CONCLUSIONS: Open-face masks are associated with decreased patient discomfort without compromising patient positioning and immobilisation accuracy.
方法:这是一项单中心随机自我对照临床试验。在CT模拟中,为每位患者制作了开放式和封闭式面罩,并为每个面罩制定了相同剂量处方的治疗计划.患者被随机分配开始使用开放式或封闭式口罩进行治疗。在治疗过程的中途更换了口罩;每个患者都是自己的对照组。患者自我报告不适,使用视觉模拟量表(VAS)进行焦虑和疼痛。使用平面kV成像和表面引导放射治疗(SGRT)系统测量了帧间和帧内设置的变异性。
结果:30例原发性或转移性脑肿瘤患者被随机分配-29例完成放疗,中位总剂量为54Gy(范围30-60Gy)。使用开放式口罩的平均不适感VAS评分显着降低(0.5,标准偏差1.0)与封闭面罩(3.3,标准偏差2.9),P<0.0001。使用开放式面罩的焦虑和疼痛VAS评分显著降低(P<0.0001)。闭合面罩在眶下(P<0.001)和上颌(P=0.02)区域引起更多不适。两名患者和27名患者更喜欢闭式或开放式口罩,分别。与与SGRT系统组合的开放式面罩相比,在与激光系统组合的封闭式面罩的情况下(P<0.05),分数间纵向移动以及滚动和偏航旋转显著更小,并且横向移动显著更大。掩模之间的内交变异性没有差异。
结论:在不影响患者定位和固定准确性的情况下,开放式面罩可降低患者的不适感。