光生物调节疗法预防化疗引起的周围神经病的应用:一项随机、安慰剂对照的初步试验(NEUROLASER 试验)。
The use of photobiomodulation therapy for the prevention of chemotherapy-induced peripheral neuropathy: a randomized, placebo-controlled pilot trial (NEUROLASER trial).
机构信息
Faculty of Medicine and Life Sciences, Hasselt University, Martelarenlaan 42, 3500, Hasselt, Belgium.
Department of Medical Oncology, Jessa Hospital, Stadsomvaart 11, 3500, Hasselt, Belgium.
出版信息
Support Care Cancer. 2022 Jun;30(6):5509-5517. doi: 10.1007/s00520-022-06975-x. Epub 2022 Mar 21.
PURPOSE
The purpose of this study was to investigate the effectiveness of photobiomodulation (PBM) therapy for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer patients.
METHODS
A prospective, randomized placebo-controlled pilot trial (NEUROLASER) was set up with 32 breast cancer patients who underwent chemotherapy (ClinicalTrials.gov; NCT03391271). Patients were randomized to receive PBM (n = 16) or placebo treatments (n = 16) (2 × /week) during their chemotherapy. The modified Total Neuropathy Score (mTNS), six-minute walk test (6MWT), Numeric pain Rating Scale (NRS), and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Taxane (FACT/GOG-Taxane) were used to evaluate the severity of CIPN and the patients' quality of life (QoL). Outcome measures were collected at the first chemotherapy session, 6 weeks after initiation of chemotherapy, at the final chemotherapy session, and 3 weeks after the end of chemotherapy (follow-up).
RESULTS
The mTNS score increased significantly over time in both the control and the PBM group. A significantly higher score for FACT/GOG-Taxane was observed in the PBM group during chemotherapy compared to the control group. Questions of the FACT/GOG-Taxane related to sensory peripheral neuropathy symptoms showed a significant increase in severeness over time in the control group, whereas they remained constant in the PBM group. At follow-up, a (borderline) significant difference was observed between both groups for the 6MWT and patients' pain level, in benefit of the PBM group.
CONCLUSIONS
This NEUROLASER trial shows promising results concerning the prevention of CIPN with PBM in breast cancer patients. Furthermore, a better QoL was observed when treated with PBM.
目的
本研究旨在探讨光生物调节(PBM)疗法预防乳腺癌患者化疗引起的周围神经病变(CIPN)的效果。
方法
开展了一项前瞻性、随机安慰剂对照的先导试验(NEUROLASER),纳入了 32 名接受化疗的乳腺癌患者(ClinicalTrials.gov;NCT03391271)。患者随机分为 PBM 组(n=16)或安慰剂组(n=16)(每周 2 次),在化疗期间接受治疗。采用改良总神经病变评分(mTNS)、6 分钟步行试验(6MWT)、数字疼痛评分量表(NRS)和癌症治疗功能评估/妇科肿瘤学组紫杉醇(FACT/GOG-紫杉醇)评估 CIPN 的严重程度和患者的生活质量(QoL)。在第一次化疗时、化疗开始后 6 周、最后一次化疗时和化疗结束后 3 周(随访)收集结局指标。
结果
在对照组和 PBM 组中,mTNS 评分随时间推移均显著增加。在化疗期间,PBM 组的 FACT/GOG-紫杉醇评分显著高于对照组。在对照组中,与感觉周围神经病变症状相关的 FACT/GOG-紫杉醇的问题在随时间推移的严重程度上显著增加,而在 PBM 组中则保持不变。在随访时,PBM 组的 6MWT 和患者疼痛水平较对照组有(边缘)显著改善。
结论
这项 NEUROLASER 试验表明,PBM 预防乳腺癌患者 CIPN 具有良好的前景,并且在接受 PBM 治疗时观察到更好的 QoL。
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