Lung NeoplasmsNCT02701231
Low-frequency Rotating Magnetic System Combined With Systemic Anti-tumor Therapy for Advanced Lung Cancer
A study testing Low-frequency Rotating Magnetic Therapy System and Systemic anti-tumor therapy in people with Lung Neoplasms, run by Chinese PLA General Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Low-frequency Rotating Magnetic Therapy System and Systemic anti-tumor therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 4 sitesChina
- Study dates
- Nov 2015to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Liang-An Chen, MD, phD, 8610-55499027, chenla301@263.net
Liang-An Chen, MD, phD
- Not yet recruiting
Affiliated hospital of Shandong University of traditional Chinese medicine
Jinan, Shandong, 250011
- Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
- Not yet recruiting
Xijing Hospital affiliated to the Fourth Military Medical University
Xi’an, Shanxi, 710032
About this study
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.
Read the 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.
- Conditions
- Lung Neoplasms
- Being tested
- Low-frequency Rotating Magnetic Therapy System, Systemic anti-tumor therapy, Sham Low-frequency Rotating Magnetic Therapy System
- Keywords
- lung cancer, Low-frequency rotating magnetic therapy system, systemic anti-tumor therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-frequency Rotating Magnetic Therapy SystemDevice
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.
Systemic anti-tumor therapyDrug
Also called Systemic therapies for advanced lung cancer
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.
Sham Low-frequency Rotating Magnetic Therapy SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham control | Sham comparator | Subjects will receive one cycle of treatment of sham low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization Receives: Drug: Systemic anti-tumor therapy; Device: Sham Low-frequency Rotating Magnetic Therapy System |
| Low-frequency Rotating Magnetic Therapy | Experimental | Subjects will receive one cycle of treatment of low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization Receives: Device: Low-frequency Rotating Magnetic Therapy System; Drug: Systemic anti-tumor therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within six weeks after randomization
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]
Measured: From first time of study treatment until 90 days after the last, assessed up to 4 months
Secondary outcomes (3)
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.
Measured: up to 5 years after the first patient randomized
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 .
Measured: up to 5 years after the first patient randomized
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.
Measured: up to 5 years after the first patient randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xijing Hospital, Shandong University of Traditional Chinese Medicine, Shandong Provincial Hospital
- Responsible party
- Principal investigator, Chen Liang_An, Chinese PLA General Hospital
- Investigators
- Liang_an Chen, MD, phD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701231
- Sponsor's protocol ID
- S2015-093-01
- Status last verified
- Mar 2016
- First submitted
- 20 Jan 2016
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Because of personal privacy, the research-related individual participant data do not intend for public sharing.
Publications
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.
PubMed 32238091
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-frequency Rotating Magnetic System Combined With Systemic Anti-tumor Therapy for Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT02701231
- Acronym / sponsor ID
- S2015-093-01
- Conditions
- Lung Neoplasms
- Keywords
- lung cancer, Low-frequency rotating magnetic therapy system, systemic anti-tumor therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Xijing Hospital, Shandong University of Traditional Chinese Medicine, Shandong Provincial Hospital
- Study start
- Nov 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham control | Sham comparator | Drug: Systemic anti-tumor therapy, Device: Sham Low-frequency Rotating Magnetic Therapy SystemSubjects will receive one cycle of treatment of sham low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization |
| Low-frequency Rotating Magnetic Therapy | Experimental | Device: Low-frequency Rotating Magnetic Therapy System, Drug: Systemic anti-tumor therapySubjects will receive one cycle of treatment of low-frequency rotating magnetic therapy system plus systemic anti-tumor therapy after randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-frequency Rotating Magnetic Therapy SystemTwo 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. | Device | Low-frequency Rotating Magnetic Therapy |
| Systemic anti-tumor therapyAlso: Systemic therapies for advanced lung cancerSystemic 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. | Drug | Low-frequency Rotating Magnetic Therapy, Sham control |
| Sham Low-frequency Rotating Magnetic Therapy SystemSham 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. | Device | Sham control |
Primary outcome
Functional Assessment of Cancer Therapy-Lung Questionaire（FACT-L）
Time frame: within six weeks after randomization
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
Time frame: From first time of study treatment until 90 days after the last, assessed up to 4 months
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]
3 secondary outcomes
Duration of response according to standard RECIST v1.1
Time frame: up to 5 years after the first patient randomized
Objective Response Rate (ORR)
Time frame: up to 5 years after the first patient randomized
Progression Free Survival（PFS）
Time frame: up to 5 years after the first patient randomized
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Derived from this study: PubMed 32238091Zhu 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.
- Individual participant dataSharing planned: No. Because of personal privacy, the research-related individual participant data do not intend for public sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang_an Chen, MD, phD principal investigator
Chinese PLA General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-frequency Rotating Magnetic Therapy System and Systemic anti-tumor therapy in people with Lung Neoplasms, run by Chinese PLA General Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang_an Chen, MD, phD (8610-55499027, chenla301@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy-Lung Questionaire（FACT-L） (time frame: within six weeks after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02701231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.