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IRCT20190904044697N2 IRCT 2019-11-02 Iran Nano Fund Positive Electrostatic therapy; selective destruction of cancer tumors through their attraction to positive charges ECT Non-invasive localized positive electrostatic therapy of malignant cancer tumors by suppression of anti-apoptotic enzymes and expression of apoptotic ones 2019-01-01 anticipated 50 Complete https://irct.ir/trial/42669 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: We investigated a new procedure based on positive electrostatic charges which induce S-arrest on malignant cells without any side-effects on normal regions. We used a patch charged by DC electrical power system to produce accumulated positive charges. Patches were attached on top of the skin. H&E, IHC, sonography, PET and confocal imaging were experimented to monitor the size and morphological states of the tumor. Signaling pathways activated during the electrostatic therapy were investigated by western blotting and Real-time PCR analyses. N/A Condition 1: Malignant cancer with solid tumor. Condition 2: Malignant cancer with solid tumor. Condition 3: Malignant cancer with solid tumor. Condition 4: Malignant cancer with solid tumor. 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. Intervention 1: Intervention group: Patients with solid malignant tumors who are candidated to get electrostatic therapy based on inclusion criteria. We use a flexible patch which is designed by nano fabrication process, charged by DC electrical power system (30kv) to produce accumulated positive charges and transfer to patients' body who candidate for study. The patch is placed on the surface of the patient's body at the nearest place to the malignant tumors. The patients are investigated after about 12 days of therapy and the outcome factors like the size of the tumor are perused. Intervention 2: Control group: The patients who candidate for the electrostatic therapy have different tumors. Some of them are at the site of the patch and getting effect from it and some of them are outside of the patch area. The tumors which are outside of the area and assumed not to have enough electrical charge are considered as control group and the changes are measured and recorded. Intervention 3: Control group: Patients with the same clinical and pathological condition with the patients who are candidated for electrostatic 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) Patients who have different types of cancer with solid tumors. Patients who the biopsy of their tumors approved that the tumors are malignant. Patients who their malignant tumors are not obey the normal cellular pathways of the tissue. Patients with malignant tumors and highest levels of invasion are more appropriate for receiving treatment (i.e. triple negative breast cancer). Patients who their tumors are not too deep and not too far from the surface of the body. Pathological or radiological evidence of malignancy Pathological or radiological evidence of progression of the disease despite classical treatments Pathological or radiological evidence of recurrence of the disease despite classical treatments At least 3 months life expectency 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. no limit no limit Both Patients who do not have appropriate general condition and need intensive care. Patients with tumors which tumor cells are obey the normal cellular pathways of the tissue. Patients who have different types of cancer which have no solid tumors. Patients with benign tumors or the types of malignant tumors which are not invasive enough. Patients who their tumors are deep and far from the surface of the skin. Coagulation disorders (INR>1.5) Pregnancy Platelets<150000 Neutropenia (neutrophil<1500) Anemia (Hemoglobin<12) Acute Infection Patients with pacemaker or any types of cardiac arrhythmia Abnormal biochemistry or electrolyte of the serum. C50 C78.7 C77 C78.0 C79.2 C73 C83.3 C22.1 C56 C48.2 Malignant neoplasm of breast Secondary malignant neoplasm of liver and intrahepatic bile duct Secondary and unspecified malignant neoplasm of lymph nodes Secondary malignant neoplasm of lung Secondary malignant neoplasm of skin Malignant neoplasm of thyroid gland Diffuse large B-cell lymphoma Intrahepatic bile duct carcinoma Malignant neoplasm of ovary Malignant neoplasm of peritoneum, unspecified Treatment - Devices Treatment - Devices Treatment - Devices Intervention group: Patients with solid malignant tumors who are candidated to get electrostatic therapy based on inclusion criteria. We use a flexible patch which is designed by nano fabrication process, charged by DC electrical power system (30kv) to produce accumulated positive charges and transfer to patients' body who candidate for study. The patch is placed on the surface of the patient's body at the nearest place to the malignant tumors. The patients are investigated after about 12 days of therapy and the outcome factors like the size of the tumor are perused. Control group: The patients who candidate for the electrostatic therapy have different tumors. Some of them are at the site of the patch and getting effect from it and some of them are outside of the patch area. The tumors which are outside of the area and assumed not to have enough electrical charge are considered as control group and the changes are measured and recorded. Control group: Patients with the same clinical and pathological condition with the patients who are candidated for electrostatic 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. Tumor sizes, Serum Tumor Marker, Clinical Manifestation , Pathological and microscopical features, Immunohistochemistry markers. In patients with end-stage cancer, their clinical and quality of life changes are investigated and the electrostatic therapy are considered as a palliative therapy. Timepoint: 12 days. Method of measurement: Imaging modalities, Blood Test, Investigating of Clinical Manifestation, Immunohistochemistry, pathological and microscopical markers and cellular staining. Quality Of Life. Timepoint: 90 days. Method of measurement: Questionnaire about quality of life indicators based on EORTC QLQ-C30. Iran Nano Fund Approved 2018-08-18 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)