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首页> 外文期刊>Breast cancer research and treatment. >COOLHAIR: a prospective randomized trial to investigate the efficacy and tolerability of scalp cooling in patients undergoing (neo)adjuvant chemotherapy for early breast cancer
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COOLHAIR: a prospective randomized trial to investigate the efficacy and tolerability of scalp cooling in patients undergoing (neo)adjuvant chemotherapy for early breast cancer

机译：Coolhair：一种预期随机试验，探讨患者（Neo）辅助化疗治疗早期乳腺癌的疗效的疗效和耐受性

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PurposeChemotherapy-induced alopecia (CIA) is a distressing side effect for women with breast cancer undergoing chemotherapy. Scalp cooling is a method aiming to prevent CIA, but its efficacy is not well defined. Randomized trials until recently and at the time this trial was designed have been lacking.MethodsPatients undergoing (neo)adjuvant chemotherapy for early breast cancer (EBC) were randomized to scalp cooling (CAP) or observation (NoCAP). All patients received 18-24weeks of anthracycline- and/or taxane-based chemotherapy. The primary endpoint was patient-reported rate of alopecia according to a modified version of the Dean Scale. Hair preservation was defined as hair lossgrade 2 (50%). Secondary endpoints were rate of alopecia determined by medical staff, rate of wig/scarf use, tolerability as well as quality of life (QoL).ResultsSeventy-nine patients were randomized. Hair preservation was observed in 39.3% of patients in the CAP arm versus 0% in the NoCAP arm (p0.001). Wig/scarf use was significantly less frequent in the CAP group (40.7% vs 95.5% outside home before cycle 3, p0.001). The drop-out rate was 31.7% and 34.2% in the CAP and NoCAP arm, respectively. Main reasons for drop-out were hair loss, adverse events (CAP), and randomization into control arm. We observed no differences in efficacy between anthracycline-based and non-anthracycline-based regimens. QoL did not differ between the study arms.ConclusionsThis trial adds to the evidence that scalp cooling effectively prevents CIA in a meaningful number of patients. This option should be made available for patients undergoing (neo)adjuvant chemotherapy for EBC.
机译：Purposechemotherapy诱导的秃头菌（CIA）是乳腺癌接受化疗的妇女的痛苦副作用。头皮冷却是一种旨在预防CIA的方法，但其功效并不明确。随机试验，直到最近和在设计这种试验时缺乏。正在进行的（Neo）早期乳腺癌（EBC）的佐剂化疗的一定程度被随机化为头皮冷却（帽）或观察（Nocap）。所有患者均接受18-24周的蒽环类和/或紫杉烷基化疗。根据Dean Scale的修改版本，主要终点是患者报告的疾病率。头发保存定义为毛发损失2（50％）。次要终点是医务人员确定的脱发率，假发/围巾使用率，可耐受性以及生活质量（QOL）.Resultsseventy-9名患者随机化。在Nocap臂的盖子臂中的39.3％患者中观察到头发保存（P <0.001）。在帽组中，假发/围巾使用频率显着较低（在循环3之前的40.7％vs 95.5％，p <0.001）。瓶盖和Noocap臂的辍学率分别为31.7％和34.2％。辍学的主要原因是脱发，不良事件（盖子）和控制臂的随机化。我们观察到基于蒽环类和非蒽环类的方案的疗效没有差异。 QOL在研究武器之间没有区别。结论司令部审判增加了头皮冷却有效地阻止CIA在有意义的患者中的证据。应提供此选项可用于接受eBC的（Neo）辅助化疗的患者。

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    Smetanay Katharina; Junio Philippe; Feisst Manuel; Seitz Julia; Hassel Jessica Cecile; Mayer Luisa; Matthies Lina Maria; Schumann Arina; Hennigs Andre; Heil Joerg; Sohn Christof; Jaeger Dirk; Schneeweiss Andreas; Marme Frederik;

  • 作者单位

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

    Univ Hosp Heidelberg Inst Med Biometry Heidelberg Germany;

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

    Univ Hosp Heidelberg Natl Ctr Tumor Dis NCT Neuenheimer Feld 460 D-69120 Heidelberg Germany;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 肿瘤学;
  • 关键词

    Alopecia; Breast cancer; Chemotherapy; Scalp cooling; Quality of life;

    机译：Alopecia;乳腺癌;化疗;头皮冷却;生活质量;

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