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IRCT20190904044697N6 IRCT 2020-09-14 Iran Nano Fund Targeted polar or charged drug delivery, using opposite electrostatic charge EDD Targeted drug delivery using polar or charged drugs by opposite electrostatic charge, in breast cancer clinical trial 2020-01-01 anticipated 40 Complete https://irct.ir/trial/49875 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: after drug preparation, it will be injected by closest possible vein to the tumor. In the next step, use the patch, by opposite charge (according to the drug charge) on the target. electrostatic patch, which connected to the electrostatic source, will cause polymer transportation (due to opposite charge) to target place. As a result, by circulating the charged drug in the body and passing through the mass, the water soluble polarized drugs are affected by the electrostatic patch of opposite charge and trapped close to the patch. The drug delivered directly to the targeted tissue. In this method, by this drug up-taking mechanism, we will reduce the injection dose dramatically and avoid drug-depended side effects on other tissues and organs. H&E, IHC, sonography, PET scan and confocal imaging were experimented to monitor the size and morphological states of the tumor. N/A Condition 1: Malignant cancer with solid tumor. Condition 2: Drug delivery. Intervention 1: Intervention group: Patients with breast cancer with assessable solid mass are nominated according to the inclusion criteria, are treated with chemotherapy drugs and opposite electrostatic charge. The patch is made using nanotechnology and is charged with a direct current electric power supply with a voltage of 30 kV, and by accumulating the opposite charge of the charged drug on the patch, the charge is transferred to the tumor site. This flexible patch is fixed on the surface of the body at the closest site to the tumor mass. The patient is treated during chemotherapy and then re-examined for mass changes. Intervention 2: Control group: The patients who candidate for the electrostatic therapy and have some tumors which are outside of the patch area and assumed not to affect enough by electrical charge, are considered as control group. Moreover, patients with the same drug and clinical and pathological condition who do not receive any EDD treatment during chemotherapy are considered as control group, too. The changes are recorded during the same period of time. It is assumed that there is not a control patient or tumor for each of participant. 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 Tehran University of Medical Sciences
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) All breast cancer type patients, with different stages, by distinguished tissue biopsy to normal one which confirmed the tumor existence. Pathological or radiological evidence of tumor existence. All breast cancer patients become a chemotherapy candidate in neoadjuvant, adjutantÙˆ and post-operative circumstance. Patients who are indicated for administration polar water-soluble or charged chemotherapy drugs such as cisplatin, carboplatib, cyclophosphamide, doxorubicin no limit no limit Both Patients who do not have appropriate general condition and need intensive care. Patients who have no assessable tumor for treatment evaluation. Coagulation disorders (INR>1.5) Thrombocytopenia (Platelets<150000) Anemia (Hemoglobin<12) Acute Infection Patients with pacemaker or any types of cardiac arrhythmia Abnormal biochemistry or electrolyte of the serum. Pregnancy Neutropenia (neutrophil<1500) Patients who are not receiving polar or charged chemotherapy drugs C50 Malignant neoplasm of breast Treatment - Devices Treatment - Drugs Intervention group: Patients with breast cancer with assessable solid mass are nominated according to the inclusion criteria, are treated with chemotherapy drugs and opposite electrostatic charge. The patch is made using nanotechnology and is charged with a direct current electric power supply with a voltage of 30 kV, and by accumulating the opposite charge of the charged drug on the patch, the charge is transferred to the tumor site. This flexible patch is fixed on the surface of the body at the closest site to the tumor mass. The patient is treated during chemotherapy and then re-examined for mass changes. Control group: The patients who candidate for the electrostatic therapy and have some tumors which are outside of the patch area and assumed not to affect enough by electrical charge, are considered as control group. Moreover, patients with the same drug and clinical and pathological condition who do not receive any EDD treatment during chemotherapy are considered as control group, too. The changes are recorded during the same period of time. It is assumed that there is not a control patient or tumor for each of participant. Accurate tumor size under patch area. Timepoint: 10 days after the first, second, third, and fourth courses of chemotherapy. Method of measurement: Imaging modalities such as sonography, mamography, MRI, etc. Serum tumor marker. Timepoint: 10 days after the first, second, third, and fourth courses of chemotherapy. Method of measurement: laboratory test on blood samples. Clinical Manifestations. Timepoint: 10 days after the first, second, third, and fourth courses of chemotherapy. Method of measurement: Accurate history taking and physical examination. Pathological and microscopical features of the tumor. Timepoint: 10 days after the first, second, third, and fourth courses of chemotherapy. Method of measurement: Biopsy taking and specific and non-specific staining of the tissue. Immunohistochemical staining. Timepoint: 10 days after the first, second, third, and fourth courses of chemotherapy. Method of measurement: Biopsy taking and specific staining of the tissue. Quality Of Life. Timepoint: 90 days. Method of measurement: Questionnaire about quality of life indicators based on EORTC QLQ-C30. Evaluating long side effects of chemotherapy drugs. Timepoint: 90 days. Method of measurement: history taking and physical examination. Iran Nano Fund Approved 2020-01-31 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)