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IRCT20190904044697N5 IRCT 2020-04-17 Iran Nano Fund Safe and short time treatment of superficial and unresectable deep tumors Clinical trial of local and short time treatment of superficial and visceral tumors using electrochemical method Based on a needle wire without any destructive effect for healthy tissues 2020-03-10 anticipated 40 Complete https://irct.ir/trial/46659 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In China and Germany, Electrochemical therapy (EChT) is considered an effective complementary treatment for cancer patients who do not respond well to surgery, chemotherapy, and radiotherapy. In this treatment, depending on the tumor size, only one to three sessions of the treatment process are performed, and there is no need to hospitalize the patient during treatment. This method has the least reported side effects compared to other treatments. In EChT, tissue electrolysis involves placing two or more electrodes, with constant current, in a tumor or its adjacent causing ionic and pH changes. This causes changes in the microenvironment surrounding the tumor and the destruction of cancer cells. In fact, in this method, the destructive products resulting from the reaction formed during the electrochemical treatment of the electrodes cause immediate cell death and long-term effects on the surrounding tissues. Severe changes in pH adjacent to the electrodes cause immediate necrosis, while secondary changes, such as a decrease in tumor perfusion, cause hypoxia and a decrease in nutriment.The disadvantage of the common EChT method is its inability to treat the deep masses, due to the damage caused by DC fields from the mass area to the skin. Therefore, with the concurrent dominance regarding the electronics technology and cancer therapist's team, we decided to modify the structure and engineering of the electric fields to apply the EChT method on a needle-shaped wire for the treatment of superficial and deep masses by laparoscopic intervention. N/A Condition 1: Malignant cancer with solid tumor. Condition 2: Benign tumor with solid mass. Condition 3: Malignant cancer with solid tumor. Condition 4: Benign tumor with solid mass. Condition 5: Malignant cancer with solid tumor. Condition 6: Malignant cancer with solid tumor. Condition 7: Malignant cancer with solid tumor. Condition 8: Malignant cancer with solid tumor. Condition 9: Malignant cancer with solid tumor. Condition 10: Malignant cancer with solid tumor. Condition 11: Malignant cancer with solid tumor. Intervention 1: Intervention group: Patients with all types of benign and malignant carcinoma tumors with evaluable solid mass that were nominated in this study according to inclusion criteria will undergo electrochemical treatment. This technique uses a needle-shaped wire that consists of two back-to-back needles separated by an insulating layer and twisted-pair conductors to prevent any charge and electric field other than the needle area in the patient's body. The voltage is then applied to the electrode in the range of 5-9 volts to provide a constant current of about 5-10 mA. The amount of charges transferred depends on the size and type of tumor. In fact, in the EChT method, the destructive effects of electrolysis created by direct DC current are used, which causes ionic and pH changes in the tumor tissue. Consequently, leads to changes in the tumor microenvironment and the destruction of cancer cells. The treatment process is monitored live under the ultrasound sonography guide throughout the treatment so that any changes in vital organs and other tissues despite the tumor mass have occurred, or if there is a problem with the patient's vital signs, can be discontinued immediately, which is one of the important capabilities of this method. Also, according to pre-clinical studies, the side effects of this study were not observed. In this method, the patient is treated for a maximum of 1 hour with an electrical power of less than 90 mW and then re-examined for tumor changes. Intervention 2: Control group: If patients undergoing electrochemical treatment have two or more tumors, this method could be used to treat the number of tumors, without any treatment for the rest of them. Tumors treated with EChT were considered as intervention group and untreated masses as controls. Since the therapeutic effect of this method is local and around the electrodes, these tumors are located a long distance from the needle electrode and are assumed not to receive DC current. Therefore, changes in these tumors are considered as changes in the control group. Intervention 3: Control group: Patients with the same clinical and pathological condition with the patients who are candidated for electrochemical therapy. They do not receive any treatment or they receive any other treatments which is not electrostatic therapy. The changes of tumor size, serum markers and clinical manifestations are recorded during the same period of time. It is assumed that there is not a control patient for each of candidate patient with different types of cancer. Yes - There is a plan to make this available What will be shared: 60% of the information about the main outcome, can be shared. When: Available 6 months after the paper has been published. To whom: The data will be available for medical staff and academic institutions. Conditions: Non-identifiable personal data will not be usable for the applicant and will only inform the patient of a positive clinical trial that the device is functioning properly Where to obtain: Applicants can request data access via email. The data will be available to the applicant in a categorized manner with pathology reports, imaging reports and serum markers by request. How to obtain: We will send the data to the applicant in 2 weeks Comments:
public Dr Mohammad Abdolahad
Nano bio electronic lab, ground floor, school of electrical and computer engineering, University of Tehran faculty of engineering, North Kargar Ave.
Tehran Iran (Islamic Republic of) 1439957131 +98 21 8802 8367 m.abdolahad@ut.ac.ir Tehran University of Medical Sciences scientific Dr Mohammad Abdolahad
Nano bio electronic lab, ground floor, school of electrical and computer engineering, University of Tehran faculty of engineering, North Kargar Ave.
Tehran Iran (Islamic Republic of) 1439957131 +98 21 8802 8367 m.abdolahad@ut.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Cancer patients who have different types of cancer with solid tumors. Patients who the biopsy results of their tumors approved that the tumors are malignant Patients with any superficial and unresectable deep tumors Patients with highest levels of invasion are more appropriate for receiving treatment (i.e. triple negative breast cancer and gastrointestinal invasive cancers) Pathological or radiological evidence of progression of the disease despite common treatments Patients with end-stage cancer who oncologists confirm that they did not profit from an alternative treatment, can include the study as a palliative therapy Patients with different types of benign and malignant tumors no limit no limit Both Patients who do not have a definable and discriminating mass to evaluate response to treatment. pregnancy Patients who do not have appropriate general condition and need intensive care. C50 D24 C22 D13.4 C77 C78.0 C79.2 C73 C56 C48 C22.1 Malignant neoplasm of breast Benign neoplasm of breast Malignant neoplasm of liver and intrahepatic bile ducts Benign neoplasm of liver Secondary and unspecified malignant neoplasm of lymph nodes Secondary malignant neoplasm of lung Secondary malignant neoplasm of skin Malignant neoplasm of thyroid gland Malignant neoplasm of ovary Malignant neoplasm of retroperitoneum and peritoneum Intrahepatic bile duct carcinoma Treatment - Devices Treatment - Devices Treatment - Devices Intervention group: Patients with all types of benign and malignant carcinoma tumors with evaluable solid mass that were nominated in this study according to inclusion criteria will undergo electrochemical treatment. This technique uses a needle-shaped wire that consists of two back-to-back needles separated by an insulating layer and twisted-pair conductors to prevent any charge and electric field other than the needle area in the patient's body. The voltage is then applied to the electrode in the range of 5-9 volts to provide a constant current of about 5-10 mA. The amount of charges transferred depends on the size and type of tumor. In fact, in the EChT method, the destructive effects of electrolysis created by direct DC current are used, which causes ionic and pH changes in the tumor tissue. Consequently, leads to changes in the tumor microenvironment and the destruction of cancer cells. The treatment process is monitored live under the ultrasound sonography guide throughout the treatment so that any changes in vital organs and other tissues despite the tumor mass have occurred, or if there is a problem with the patient's vital signs, can be discontinued immediately, which is one of the important capabilities of this method. Also, according to pre-clinical studies, the side effects of this study were not observed. In this method, the patient is treated for a maximum of 1 hour with an electrical power of less than 90 mW and then re-examined for tumor changes. Control group: If patients undergoing electrochemical treatment have two or more tumors, this method could be used to treat the number of tumors, without any treatment for the rest of them. Tumors treated with EChT were considered as intervention group and untreated masses as controls. Since the therapeutic effect of this method is local and around the electrodes, these tumors are located a long distance from the needle electrode and are assumed not to receive DC current. Therefore, changes in these tumors are considered as changes in the control group. Control group: Patients with the same clinical and pathological condition with the patients who are candidated for electrochemical therapy. They do not receive any treatment or they receive any other treatments which is not electrostatic therapy. The changes of tumor size, serum markers and clinical manifestations are recorded during the same period of time. It is assumed that there is not a control patient for each of candidate patient with different types of cancer. Changes in the size and extent of tumor necrosis. Timepoint: one week. Method of measurement: Imaging modalities (Conventional ultrasound and especially Doppler ultrasound, MRI and CT scan), Immunohistochemistry, pathological and microscopical markers and cellular staining. Clinical and quality of life changes. Timepoint: Every day. Method of measurement: Blood Test, Investigating of Clinical Manifestation. Quality Of Life. Timepoint: 90 days. Method of measurement: Questionnaire about quality of life indicators based on EORTC QLQ-C30. Iran Nano Fund Approved 2020-03-09 Ethics committee of Tehran University of Medical Science No.23, 16 Azar Ave, Tehran Ave., Tehran, Iran Postal Code: 1417863181 Tehran Tehran Iran (Islamic Republic of)