Pires André M, Carvalho Luísa, Santos Ana C, Vilaça Ana M, Coelho Ana R, Oliveira Celeste, Costa Céline, Fernandes Flávia, Moreira Liliana, Lima João, Vieira Rafaela, Ferraz Maria J, Silva Marta, Silva Pedro, Matias Rafael, Zorro Sara, Costa Susana, Sarandão Susana, Barros Ana F
Radiation Oncology Department, Portuguese Institute of Oncology of Porto, R. Dr António Bernardino de Almeida, Porto, Portugal.
Adv Radiat Oncol. 2023 Nov 5;9(3):101404. doi: 10.1016/j.adro.2023.101404. eCollection 2024 Mar.
Most of radiation oncology centers rely on set-up skin markings for patient setup during treatment delivery. Permanent dark-ink tattooing is the most popular marking method. COMFORTATTOO is a unicentric, randomized trial testing 2 permanent methods: lancets against an electric marking pen (Comfort Marker 2.0, CM). One substudy was undertaken to test if using the CM translates into a cosmesis, fading, or satisfaction benefit compared with the lancets.
Patients aged 18 years or older referred to our department to receive RT were recruited. They were randomly assigned, in a 1:1 ratio, to receive set-up markings using lancets or CM. This substudy aimed to recruit all the living participants included in the main study. The primary endpoints were tattoos cosmesis, tattoos fading, and patients' satisfaction 6 months after finishing the RT. Cosmetic and fading assessments were scored on a 5-point ascending scale and patients' satisfaction on a 10-point ascending scale. The trial is registered at ClinicalTrials.gov (number NCT05371795).
Between April and September 2022, 92 patients were enrolled (45 assigned to lancets and 47 to CM) and assessed for the outcomes. Patients receiving CM had significantly better cosmetic markings, with a median score of 4.4 (vs 3.7 for lancets, <.001). On the fading assessment, the CM was associated with lower scores compared with the lancets (median score of 1.3 and 3.3, respectively; <.001). No differences in patients' satisfaction were observed with either method (median score of 10 for both arms, =.952).
Our substudy results demonstrated that, 6 months after the end of RT, the CM produces better cosmetic markings with less fading compared with the lancets. These differences didn't translate into patients' satisfaction superiority toward any method.
大多数放射肿瘤学中心在治疗过程中依靠设置皮肤标记来进行患者定位。永久性深色墨水纹身是最常用的标记方法。COMFORTATTOO是一项单中心随机试验，测试两种永久性方法：柳叶刀与电动标记笔（Comfort Marker 2.0，CM）。进行了一项子研究，以测试与柳叶刀相比，使用CM是否会在美容效果、褪色或满意度方面带来益处。
招募了18岁及以上转诊至我院接受放疗的患者。他们以1:1的比例随机分配，接受使用柳叶刀或CM进行的定位标记。该子研究旨在招募纳入主要研究的所有在世参与者。主要终点是放疗结束6个月后的纹身美容效果、纹身褪色情况和患者满意度。美容和褪色评估采用5分升序评分，患者满意度采用10分升序评分。该试验已在ClinicalTrials.gov注册（编号NCT05371795）。
2022年4月至9月，92名患者入组（45名分配至柳叶刀组，47名分配至CM组）并进行了结果评估。接受CM的患者纹身美容效果明显更好，中位数评分为4.4（柳叶刀组为3.7，P<0.001）。在褪色评估中，与柳叶刀相比，CM的评分更低（中位数分别为1.3和3.3；P<0.001）。两种方法在患者满意度方面均未观察到差异（两组中位数评分均为10，P = 0.952）。
我们的子研究结果表明，放疗结束6个月后，与柳叶刀相比，CM产生的纹身美容效果更好，褪色更少。这些差异并未转化为患者对任何一种方法的满意度优势。
