Clinical trial NCT02701231: Low-frequency Rotating Magnetic System Combined With Systemic Anti-tumor Therapy for Advanced Lung Cancer
Official title: Low-frequency Rotating Magnetic System Combined With Systemic Anti-tumor Therapy for Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasms
Keywords: lung cancer
Low-frequency rotating magnetic therapy system
systemic anti-tumor therapy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Xijing Hospital
name: Shandong University of Traditional Chinese Medicine
name: Shandong Provincial Hospital
First posted: 2016-03-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy-Lung Questionaire（FACT-L）
timeFrame: within six weeks after randomization
measure: Number of Participants With Adverse Events That Are Related to Treatment
timeFrame: From first time of study treatment until 90 days after the last, assessed up to 4 months
Secondary outcomes:
measure: Duration of response according to standard RECIST v1.1
timeFrame: up to 5 years after the first patient randomized
measure: Objective Response Rate (ORR)
timeFrame: up to 5 years after the first patient randomized
measure: Progression Free Survival（PFS）
timeFrame: up to 5 years after the first patient randomized
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Jinan
country: China
facility: Affiliated hospital of Shandong University of traditional Chinese medicine
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Xi'an
country: China
facility: Xijing Hospital affiliated to the Fourth Military Medical University
state: Shanxi
Study officials:
affiliation: Chinese PLA General Hospital
name: Liang_an Chen, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu M, Yang Z, Yu H, Zhu Q, Xu Y, Li Y, Li C, Zhao W, Liang Z, Chen L. 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. Int J Radiat Biol. 2020 Jul;96(7):943-950. doi: 10.1080/09553002.2020.1748737. Epub 2020 Apr 13.