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

Primary Purpose

Lung Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low-frequency Rotating Magnetic Therapy System
Systemic anti-tumor therapy
Sham Low-frequency Rotating Magnetic Therapy System
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring lung cancer, Low-frequency rotating magnetic therapy system, systemic anti-tumor therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chinese PLA General HospitalRecruiting
  • Affiliated hospital of Shandong University of traditional Chinese medicine
  • Shandong Provincial Hospital
  • Xijing Hospital affiliated to the Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham control

Low-frequency Rotating Magnetic Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Functional Assessment of Cancer Therapy-Lung Questionaire（FACT-L）
Use the FACT-L to assess the effiency of low-frequency rotating magnetic system on the improvement of patients' quality of life
Number of Participants With Adverse Events That Are Related to Treatment
AEs: Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE 4.0]

Secondary Outcome Measures

Duration of response according to standard RECIST v1.1
At each visit subjects will be programmatically assigned a RECIST visit response of CR, PR, SD or PD depending on the status of their disease compared to baseline and previous assessments. Duration of response: the time from the first documentation of CR or PR or SD to objective disease progression (PD) or death from any cause.
Objective Response Rate (ORR)
At each visit subjects will be programmatically assigned a RECIST visit response of CR, PR, SD or PD depending on the status of their disease compared to baseline and previous assessments. Objective response rate: the percentage of subjects who have at least one visit response of CR or PR prior to any evidence of progression .
Progression Free Survival（PFS）
At each visit subjects will be programmatically assigned a RECIST visit response of CR, PR, SD or PD depending on the status of their disease compared to baseline and previous assessments. Progression Free Survival (PFS) : the time from start of study treatment to the first documentation of objective disease progression (PD) or death from any cause.

Full Information

First Posted
January 20, 2016
Last Updated
March 8, 2016
Sponsor
Chinese PLA General Hospital
Collaborators
Xijing Hospital, Shandong University of Traditional Chinese Medicine, Shandong Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02701231
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Xijing Hospital, Shandong University of Traditional Chinese Medicine, Shandong Provincial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
lung cancer, Low-frequency rotating magnetic therapy system, systemic anti-tumor therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
Subjects will receive one cycle of treatment of sham low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization
Arm Title
Low-frequency Rotating Magnetic Therapy
Arm Type
Experimental
Arm Description
Subjects will receive one cycle of treatment of low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization
Intervention Type
Device
Intervention Name(s)
Low-frequency Rotating Magnetic Therapy System
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Systemic anti-tumor therapy
Other Intervention Name(s)
Systemic therapies for advanced lung cancer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Low-frequency Rotating Magnetic Therapy System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy-Lung Questionaire（FACT-L）
Description
Use the FACT-L to assess the effiency of low-frequency rotating magnetic system on the improvement of patients' quality of life
Time Frame
within six weeks after randomization
Title
Number of Participants With Adverse Events That Are Related to Treatment
Description
AEs: Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE 4.0]
Time Frame
From first time of study treatment until 90 days after the last, assessed up to 4 months
Secondary Outcome Measure Information:
Title
Duration of response according to standard RECIST v1.1
Description
At each visit subjects will be programmatically assigned a RECIST visit response of CR, PR, SD or PD depending on the status of their disease compared to baseline and previous assessments. Duration of response: the time from the first documentation of CR or PR or SD to objective disease progression (PD) or death from any cause.
Time Frame
up to 5 years after the first patient randomized
Title
Objective Response Rate (ORR)
Description
At each visit subjects will be programmatically assigned a RECIST visit response of CR, PR, SD or PD depending on the status of their disease compared to baseline and previous assessments. Objective response rate: the percentage of subjects who have at least one visit response of CR or PR prior to any evidence of progression .
Time Frame
up to 5 years after the first patient randomized
Title
Progression Free Survival（PFS）
Description
At each visit subjects will be programmatically assigned a RECIST visit response of CR, PR, SD or PD depending on the status of their disease compared to baseline and previous assessments. Progression Free Survival (PFS) : the time from start of study treatment to the first documentation of objective disease progression (PD) or death from any cause.
Time Frame
up to 5 years after the first patient randomized

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liang_an Chen, MD, phD
Phone
8610-55499027
Email
chenla301@263.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang_an Chen, MD, phD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang-An Chen, MD, phD
Phone
8610-55499027
Email
chenla301@263.net
First Name & Middle Initial & Last Name & Degree
Liang-An Chen, MD, phD
Facility Name
Affiliated hospital of Shandong University of traditional Chinese medicine
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250011
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Xijing Hospital affiliated to the Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Because of personal privacy, the research-related individual participant data do not intend for public sharing.
Citations:
PubMed Identifier
32238091
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.
Results Reference
derived

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

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