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

NCT02701231 | Unknown DMC

• 1 other identifier: S2015-093-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Lung Neoplasms

Keywords

lung cancer; Low-frequency rotating magnetic therapy system; systemic anti-tumor therapy

Outcome Measures

Primary Outcomes (2)

• 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

  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 \[CTCAE 4.0\]

  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

  up to 5 years after the first patient randomized

• Objective Response Rate (ORR)

  up to 5 years after the first patient randomized

• Progression Free Survival（PFS）

  up to 5 years after the first patient randomized

Study Arms (2)

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

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

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

Interventions

Low-frequency Rotating Magnetic Therapy System DEVICE

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.

Low-frequency Rotating Magnetic Therapy

Systemic anti-tumor therapy DRUG

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.

Also known as: Systemic therapies for advanced lung cancer

Low-frequency Rotating Magnetic Therapy; Sham control

Sham Low-frequency Rotating Magnetic Therapy System DEVICE

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.

Sham control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Xijing Hospital: collaborator
• Shandong University of Traditional Chinese Medicine: collaborator
• Shandong Provincial Hospital: collaborator

Study Sites (4)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Affiliated hospital of Shandong University of traditional Chinese medicine

Jinan, Shandong, 250011, China

NOT YET RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

NOT YET RECRUITING

Xijing Hospital affiliated to the Fourth Military Medical University

Xi’an, Shanxi, 710032, China

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 32238091 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Liang_an Chen, MD, phD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang_an Chen, MD, phD

CONTACT

8610-55499027; chenla301@263.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of respiratory medicine

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: March 8, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 9, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)