Dupoiron Denis, Bienfait Florent, Seegers Valérie, Piloquet François-Xavier, Pluchon Yves-Marie, Pechard Marie, Mezaib Karima, Chvetzoff Gisèle, Diaz Jésus, Ahmeidi Abesse, Mauriès-Saffon Valérie, Lebrec Nathalie, Jubier-Hamon Sabrina
Anaesthesiology and Pain Department, Institut de Cancérologie de l'Ouest, 49055 Angers, France.
Biometrics Department, Institut de Cancérologie de l'Ouest, 49055 Angers, France.
Cancers (Basel). 2025 Jan 19;17(2):313. doi: 10.3390/cancers17020313.
CAPTRANE evaluated the efficacy and tolerability of high-concentration capsaicin patch (HCCP) vs. oral pregabalin for the treatment of postsurgical neuropathic pain (PSNP) following breast cancer surgery. The study was designed with the aim of demonstrating noninferiority of one HCCP against daily pregabalin. This was a multicenter, randomized, parallel-arm, open-label study conducted across nine centers in France. The primary endpoint was a change from baseline in the Numeric Pain Rating Scale (NPRS) score after 2 months. Recruitment challenges resulted in the randomization of 140 patients (versus 644 planned); the per-protocol population comprised 107 patients (HCCP: n = 65; pregabalin: n = 42). Baseline characteristics were similar between the two groups. In the per-protocol analysis, the mean (standard deviation) change versus baseline in NPRS score was -1.926 (2.554) with HCCP and -1.634 (2.498) with pregabalin. The prespecified analysis showed that HCCP was not inferior to pregabalin: the lower bound of the 90% confidence interval for the between-arm difference was -0.889 and the upper bound was +0.260 (i.e., below the predefined clinical threshold of +0.4). Patient-reported outcomes showed no statistically significant differences between treatments. The painful area size decreased significantly more with HCCP. Tolerability profiles differed, with HCCP mostly causing application-site reactions. While >50% of patients switched from pregabalin to HCCP, none switched from HCCP to pregabalin. This comparative study in PSNP post breast cancer surgery, evaluating a single treatment of HCCP, shows a noninferior reduction in pain intensity, a superior reduction in painful area size, and a patient preference for HCCP compared with pregabalin. Despite limitations, it contributes valuable initial data for PSNP management in breast cancer care.
CAPTRANE研究评估了高浓度辣椒素贴片（HCCP）与口服普瑞巴林治疗乳腺癌手术后手术部位神经性疼痛（PSNP）的疗效和耐受性。该研究旨在证明一种HCCP相对于每日服用普瑞巴林的非劣效性。这是一项在法国九个中心进行的多中心、随机、平行组、开放标签研究。主要终点是2个月后数字疼痛评分量表（NPRS）得分相对于基线的变化。招募方面的困难导致140名患者被随机分组（而计划为644名）；符合方案人群包括107名患者（HCCP组：n = 65；普瑞巴林组：n = 42）。两组的基线特征相似。在符合方案分析中，HCCP组NPRS得分相对于基线的平均（标准差）变化为-1.926（2.554），普瑞巴林组为-1.634（2.498）。预先设定的分析表明，HCCP不劣于普瑞巴林：组间差异的90%置信区间下限为-0.889，上限为+0.260（即低于预先定义的临床阈值+0.4）。患者报告的结果显示，各治疗组之间无统计学显著差异。HCCP使疼痛区域大小的减小更为显著。耐受性特征有所不同，HCCP主要引起用药部位反应。虽然超过50%的患者从普瑞巴林改用HCCP，但无人从HCCP改用普瑞巴林。这项针对乳腺癌手术后PSNP的比较研究，评估了单一的HCCP治疗，结果显示与普瑞巴林相比，HCCP在减轻疼痛强度方面具有非劣效性，在减小疼痛区域大小方面效果更优，且患者更倾向于使用HCCP。尽管存在局限性，但它为乳腺癌护理中PSNP的管理提供了有价值的初始数据。
