The efficacy and safety of low-frequency rotating static magnetic field therapy combined with chemotherapy on advanced lung cancer patients: a randomized, double-blinded, controlled clinical trial

摘要

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.