Purpose: To evaluate the efficacy and safety of magnetic field (MF) therapy by a randomized, double-blinded, controlled clinical trial.

Materials and methods: From February 2016 to August 2019, patients with advanced lung cancer who conformed to inclusion criteria were enrolled in this study. Patients were assigned into MF therapy group (MF group, receiving both MF therapy and chemotherapy) and control group (CON group, receiving sham MF therapy and chemotherapy) randomly. The treatment course was 21 days and 2 hours per day. Changes of life quality assessment scales, objective response rate (ORR) and disease control rate (DCR) were analyzed as primary end points. The secondary end points were progression-free survival (PFS), change of blood cytokine concentrations and safety. This study has been registered on Clinicaltrials.gov (ID: NCT02701231).

Results: 77 patients were enrolled and 60 finished the study. Comparing to CON group, more patients in MF group (66.7% vs 25.9%) were experiencing life quality improvement on day 21. Besides, MF group patients had higher concentrations of IP-10 and GM-CSF, and lower concentration of sTREM-1 in plasma. However, the two groups were having similar ORR, DCR and PFS after treatment. Moreover, MF treatment did not increase adverse events in MF group.

Conclusions: MF therapy could improve life quality and modulate blood cytokine concentration in advanced lung cancer patients. Hence, it might be applied as an adjuvant therapy along with chemotherapy.

目的：通过一项随机，双盲，对照临床试验评估磁场（MF）治疗的有效性和安全性。

材料和方法：自2016年2月至2019年8月，符合纳入标准的晚期肺癌患者入选本研究。将患者随机分为MF治疗组（MF组，同时接受MF治疗和化疗）和对照组（CON组，接受假MF治疗和化疗）。治疗过程为每天21天2小时。以生活质量评估量表，客观反应率（ORR）和疾病控制率（DCR）的变化为主要终点。次要终点是无进展生存期（PFS），血细胞因子浓度变化和安全性。该研究已在Clinicaltrials.gov（ID：NCT02701231）上进行了注册。

结果：招募了77例患者，其中60例完成了研究。与CON组相比，MF组在第21天的生活质量有所改善（66.7％比25.9％）。此外，MF组患者的IP-10和GM-CSF浓度较高，而sTREM-1浓度较低在血浆中。然而，两组在治疗后的ORR，DCR和PFS相似。此外，MF治疗并没有增加MF组的不良反应。

结论： MF疗法可改善晚期肺癌患者的生活质量并调节其血液细胞因子浓度。因此，它可以与化学疗法一起用作辅助疗法。