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

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Lung Neoplasms

Treatments: Drug: Systemic anti-tumor therapy; Device: Sham Low-frequency Rotating Magnetic Therapy System; Device: Low-frequency Rotating Magnetic Therapy System

Study type: Interventional

Funder types: Other

Identifiers

NCT02701231

S2015-093-01

Details and patient eligibility

About

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.

Full description

The purpose of this study is to assess the efficacy and safety of the Low-frequency Rotating Magnetic Therapy System(with systemic anti-tumor therapy) compared to systemic anti-tumor therapy in patients suffering from advanced lung cancer.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to give written informed consent
• Male or female aged 18 years and older
• Histologic diagnosis of non-small cell lung cancer (unable to receive surgery) or small cell lung cancer (limited stage or extensive stage)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3- going to receive systemic anti-tumor therapy
• Measurable disease based on RECIST 1.1
• Adequate hematologic and organ function

Exclusion criteria

• Currently participating and receiving study therapy in, or has participated in a study of an investigational agent and received study therapy or used an investigational device
• Unable to lie in bed
• With any metal implants in body
• Human immunodeficiency virus (HIV)
• Malignancies other than lung cancer within 5 years prior to randomization
• History or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial or interfere with the subject's participation for the full duration of the trial
• Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Sham control

Sham Comparator group

Description:

Subjects will receive one cycle of treatment of sham low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization

Treatment:

Device: Sham Low-frequency Rotating Magnetic Therapy System

Drug: Systemic anti-tumor therapy

Low-frequency Rotating Magnetic Therapy

Experimental group

Description:

Subjects will receive one cycle of treatment of low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization

Treatment:

Device: Low-frequency Rotating Magnetic Therapy System

Drug: Systemic anti-tumor therapy