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首页> 外文期刊>Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer >Scrambler therapy for chemotherapy neuropathy: a randomized phase II pilot trial
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Scrambler therapy for chemotherapy neuropathy: a randomized phase II pilot trial

机译:化疗治疗神经病变:随机第二阶段试验试验

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Introduction Chemotherapy-induced peripheral neuropathy (CIPN) is a prominent clinical problem, with limited effective therapies. Preliminary non-randomized clinical trial data support that Scrambler Therapy is helpful in this situation. Methods Patients were eligible if they had CIPN symptoms for at least 3 months and CIPN-related tingling or pain at least 4/10 in severity during the week prior to registration. They were randomized to receive Scrambler Therapy versus transcutaneous electrical nerve stimulation (TENS) for 2 weeks. Patient-reported outcomes (PROs) were utilized to measure efficacy and toxicity daily for 2 weeks during therapy and then weekly for 8 additional weeks. Results This study accrued 50 patients, 25 to each of the 2 study arms; 46 patients were evaluable. There were twice as many Scrambler-treated patients who had at least a 50% documented improvement during the 2 treatment weeks, from their baseline pain, tingling, and numbness scores, when compared with the TENS-treated patients (from 36 to 56% compared with 16-28% for each symptom). Global Impression of Change scores for "neuropathy symptoms," pain, and quality of life were similarly improved during the treatment weeks. Patients in the Scrambler group were more likely than those in the TENS group to recommend their treatment to other patients, during both the 2-week treatment period and the 8-week follow-up period (p < 0.0001). Minimal toxicity was observed. Conclusions The results from this pilot trial were positive, supporting the conduct of further investigations regarding the use of Scrambler Therapy for treating CIPN.
机译:引言化疗诱导的周围神经病变(CIPN)是一个突出的临床问题,有限的有效疗法。初步非随机临床试验数据支持,扰乱治疗在这种情况下有所帮助。方法如果在注册前一周,患者患者患有CIPN症状至少3个月和至少4/10的CIPN相关刺痛或疼痛。它们被随机地接受爬行器治疗与经皮辐射刺激(TENS)进行2周。患者报告的结果(优点)用于在治疗期间每天2周测量疗效和毒性,然后每周持续8周。结果本研究累计50名患者,25例到2个研究武器中的每一个; 46名患者是可评估的。与TES治疗患者相比每个症状为16-28%)。在治疗周内类似地改善了“神经病变症状”,疼痛和生活质量的全球变化评分。爬行剂组中的患者比TENS组中的患者更可能向其他患者的治疗,在2周治疗期和8周的随访期间(P <0.0001)。观察到最小的毒性。结论该试验试验结果是阳性的,支持进一步调查关于使用爬行剂治疗CIPN的进一步调查。

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