| [Background]Cancer is becoming the leading cause of human death in the 21st century. It is predicted that new cases of cancer will reach 15 million, death cases will reach 10 million, and present cases will reach 30 million by 2020 in China. However, the treatment of cancer is not satisfied so far, whether the traditional surgery, radiotherapy, chemotherapy or the newly developing biological treatment. Their survival time and quality of life has not changed obviously, especially for the advanced cancer patients. So it is urgent to find new methods, new technologies to treat on cancer.Magnetic fields being used to health territory has a long time. There are records of using magnet to cure disease more than 2000 years ago in our country in the Western Han dynasty, and the earliest foreign records can date back to 200 BC. Biological magnetotherapy group and biological magnetotherapy research institute were founded in the UK in 1995, and in 1996 the first international magnetotherapy conference held there. In 2004, the American FDA approved magnetic therapy being applied in intractable fractures.Many experiment reports suggest that magnetic fields have obvious inhibitory effect on tumor cells. Some researchers put natural killer cells (NK) in extremely low-frequency magnetic fields (square wave 0.8 Hz, the maximum field strength 120 mT), found that the activity of NK cells improved after 5 days, prompting that this kind of magnetic fields can help control cancer; Some have found that low frequency rectangular magnetic fields of 4 mT,15 Hz could make the osteoblast proliferate significantly; Some reported the growth of rat S 180 sarcoma cells was restrained after dealing with the extremely low-frequency magnetic fields. But so far, major research work about the biological effects of magnetic fields on tumor cells is still limited in the lab, there are a few clinical reports.ChaoRuiShi Company in Shandong accidentally observed that low-frequency magnetic fields was effective for patients with tumor, and after the study of a large number of experimental analysis at home and abroad, they created low-frequency magnetic fields therapy system. It is included in the National Science & Technology Pillar Program during the 12th Five-year Plan Period.The Academician team of Chinese academy of sciences did the test on cells in vitro and animal models in the Medicine School of Nanjing University. The result showed that low requency-magnetic fields could selectively inhibit the proliferation of tumor cells, and the number of immune cells increased significantly, the survival of experimental group significantly prolonged compared with control group. Men sun Yun academician team of Chinese academy of engineering, measured the parameters of the low-frequency magnetic fields to realize the real-time dynamic dose control, and laid a foundation to improve the treatment level of low-frequency magnetic fields therapy system. The medical protection of electromagnetic radiation in Third military medical university, key laboratory of education ministry, did the safety testing on animals of low-frequency magnetic fields treatment systems, showing that the system is safe under the current operating parameters.Above all, the low-frequency magnetic fields treatment brought hope for patients with advanced cancer. There is an urgent need to systemic clinical research, to find specific parameters of low-frequency magnetic fields for positive intervention effect of cancer.[Objective]This study is to research the clinical safety and efficacy of the low-frequency magnetic fields treatment under specific parameters for advanced cancer patients who are not suitable for surgery, radiotherapy, chemotherapy or other anti-tumor treatment,to evaluation if low-frequency magnetic fields treatment can improve the quality of life and the living conditions, to analyze factors affecting the prognosis of survival, so that the low-frequency magnetic fields can apply to clinical as soon as possible, thus creating a new, effective mode of cancer therapy.[Methods]1、clinical dataBetween March 2009 and February 2013, in Shandong provincial hospital,257 patients with histological or cytological confirmation of advanced cancer were considered as candidates in this pilot study.2、the distribution of treatment group131 patients were included in the treatment group:low-frequency magnetic fields treatment with best support, until death or being asked to quit.126 patients were included in the control group:only giving the best support treatment, until death or being asked to quit.3、research plan for treatment groupIn this study, we use the ZCX-II low-frequency magnetic fields treatment system(The patent number: ZL200820025132.X;sample number: 2006021522),which is designed by Shandong Chaoruishi medical science and technology company. The MFs of the device is alternative pulses which could be regulated from 0.38 to 0.42 T. The rotate speed of magnetic heads can be regulated from 300r/min to 600r/min.All the 131 patients of treatment group were exposed to a 420r/min,0.4 T low-frequency magnetic fields. An area included the primary tumor site, metastatic sites, and metastatic lymph nodes. And the patients were treated daily,2 hours one day for 30-60 days, average time of 42 days.Evaluate KPS score and QOL score of patients before and after the treatment for a week, to determine the clinical curative effect. Evaluation standard is as follows: QOL or KPS change ratio= (score after treatment-score before treatment/score before treatment)× 100%, the change rate of 70%or higher represents complete response, change rate between 40% and 60% represents partial response,change rate below 40% means no response. Clinical benefit is the sum of complete response and partial response.During the treatment progress, patients were observed whether they had severe side effects. Adverse events associated with magnetic therapy products should be reported.4、Follow-up and statistics analysisThe follow-up methods include outpatient service and telephone interview. And the statistics methods include SPSS 17.0 for statistical analysis, Kaplan Meier method for survival analysis, Log-rank test to compare the survival of the differences between two groups, Cox multiple factors regression analysis for independent prognostic factors.[Results]Part I the results of 131 patients who accepted low-frequency magnetic fields1. Clinical features and therapeutic evaluationThere were 30 lung cancer patients, stomach cancer 21, liver cancer 19, esophageal cancer 18, and colorectal cancer 17, breast cancer 26 patients in this group. 75 cases were Male patients while 56 cases were female. The youngest one is 26 years old, the oldest 85. After the low-frequency magnetic fields,24 cases showed complete response,56 showed partial response.80 cases had clinical benefits,51 cases showed no response, the clinical benefit rate was 61.1%. The patient’s KPS index, QOL index before treatment, primary tumor site and number of low-frequency magnetic fields treatment correlated significantly with the clinical benefit rate(P=0.016,0.005,0.003, and 0.026 respectively).2. Survival outcomesThe patient’s median survival time in low-frequency magnetic fields treatment group was 9.7 months(95%CI:8.269-11.131 months).107 cases ceased,24 cases lived, and the 1-year,2-year survival rates were 38.0%,8.3% respectively.3. The single factor prognosis analysisThe patient’s KPS index, QOL index before treatment, primary tumor site and number of low-frequency magnetic fields treatment correlate significantly with the survival time(P=0.000,0.037,0.027, and 0.016 respectively).4. The multifactorial prognosis analysisThe patient’s KPS index before treatment was independent survival prognostic factor.5. Safety analysisAll of the 131 patients finished the low-frequency magnetic fields treatment, and no one showed obvious side effects or severe complications.13 cases (9.9%) presented malaise, fatigue, mild dull pain or pinching pain at diseased site. Grades 1 and 2 arrest of bone marrow was detected in 16 (12.2%) patients and 5 (3.8%) patient, respectively. Increased heart rate of 3-5 bpm was observed in 10 (7.6%) patients. There was an increase of temperature of 0.5-1.0℃ in 7 (5.3%) patients. No patients died duo to treatment.Part II the research results of whole group 257 cancer patients.1. Clinical featuresThere were 58 lung cancer patients, stomach cancer 42, liver cancer 39, esophageal cancer 37, colorectal cancer 33, breast cancer 48 patients the whole group. Of these 257 subjects,108 were female and 149 were male and the median age was 62 years (range,27-84). There were no significant differences between low-frequency magnetic fields treatment group and control group in sex, age, KPS index, QOL index, previous treatment approaches, primary tumor sites and the number of the metastatic sites et cetera.2. The whole group survival outcomesThe patient’s median survival time was 9.1 months (95%CI:8.294-9.906 months).216 cases ceased,41 cases lived, and the 1-year,2-year,3-year survival rates were 34.3%,6.8%, and 2.7%respectively.3. The patients’survival curve between treatment group and control groupThe median survival time (9.7 months) of low-frequency magnetic fields treatment group patients is longer than 1.1 months as opposed to control group patients. The difference had statistical significance (P=0.028).4. The whole group single factor prognosis analysisThe patients’KPS index, QOL index, primary tumor sites and whether or not accepting low-frequency magnetic fields treatment correlated significantly with the survival time (P=0.000,0.006,0.020,0.028 respectively).5. The whole group multifactorial prognosis analysisThe patients’KPS index, whether or not accepting low-frequency magnetic fields treatment were independent survival prognostic factors (P=0.000,0.014 respectively).[Conclusion]1. The advanced malignancies’treatment with low-frequency magnetic fields had higher safety. Patients showed better endurance, and there were no obvious side effects or severe complications, and no ceased cases due to treatment.2. The low-frequency magnetic fields had better therapeutic effects, which could improve patients’KPS index, QOL index, and quality of life of advanced cancer patients.3. Low-frequency magnetic fields treatment could prolong the overall survival time of advanced cancer patients about 1.1 months compared with the best supportive care (9.7 months as opposed to 8.6 months).4. The whole group single factor prognosis analysis results indicated that the patients’ KPS index, QOL index, primary tumor sites and whether or not accepting low-frequency magnetic fields treatment correlated significantly with the survival time.5. The whole group multifactorial prognosis analysis results showed the patients’ KPS index, whether or not accepting low-frequency magnetic fields treatment were independent survival prognostic factors.[Research significance and outlook]In 2012, the national sic-tech support plan "systemic research and development of low-frequency magnetic fields treatment" project was approved. This research was one part of the project, and some results were obtained. This research illustrated how the low-frequency magnetic fields worked, which transformed the human body from disorder state to order state by interacting between the external electromagnetic fields and the biological electromagnetic fields of human body so as to kill cancer. This may broaden a brand-new horizon for the treatment of cancer, and deserved deeper research.A prospective, multicenter, randomized, double blind clinical trial had been launched recently, which were conducted cooperatively by Chinese PLA general hospital, Shandong provincial hospital affiliated to Shandong University and the first hospital affiliated to the Fourth Military Medical School, and assessed the value of the low-frequency magnetic fields in the improvement of quality of life for the end-stage lung cancer patients. It’s expected more and more progresses will be made in this field in the near future. |
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