Low-frequency Rotating Magnetic System Combined With Systemic Anti-tumor Therapy for Advanced Lung Cancer

Summary

The purpose of this study is to determine whether Low-frequency Rotating Magnetic Therapy System is effective and safe in the treatment of advanced lung cancer.

Conditions

• Lung Neoplasms

Interventions

DEVICE

Low-frequency Rotating Magnetic Therapy System

Two pairs of fan-shaped NdFeB permanent magnets were attached to a circular iron plate and arranged to establish magnetic field. The bottom two magnets rotated at certain frequency driven by a step motor, which was controlled using a functional signal generator. The top two magnets rotated synchronously due to the strong magnetic interaction. Magnetic flux density was measured at the target site using a gauss meter. The entire magnetic apparatus was located in a hood with humidity and temperature controller.

DRUG

Systemic anti-tumor therapy

Systemic anti-tumor therapy includes targeted therapies, chemotherapy and best supportive care, according to NCCN non-small cell lung cancer(NSCLC) and small cell lung cancer(SCLC) guidelines. SCLC patients will receive six cycles of cisplatin and etoposide. NSCLC patients will receive EGFR and ALK test. With sensitive result the first-line therapy will be Erlotinib/Gefitinib/Crizotinib. If insensitive, the patient will receive six cycles of cisplatin and pemetrexed. Then the patient will receive tumor response evaluation. The patient with response or stable disease will receive maintenance therapy with one or some of the drugs including bevacizumab, pemetrexed, gemcitabine and docetaxel until disease progression. During experience all patients will receive clinical observation. Once proven for disease progression the patient will finish the experiment.

DEVICE

Sham Low-frequency Rotating Magnetic Therapy System

Sham Low-frequency Rotating Magnetic Therapy System is a similar apparatus except that there were two rotating iron plates instead of magnets, thus lacking a magnetic field.

Sponsors & Collaborators

• Xijing Hospital

  collaborator OTHER

• Shandong University of Traditional Chinese Medicine

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Chinese PLA General Hospital

  lead OTHER

Principal Investigators

• Liang_an Chen, MD, phD · Chinese PLA General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• China

Study Locations