Non-invasive localized positive electrostatic therapy of malignant cancer tumors by suppression of anti-apoptotic enzymes and expression of apoptotic ones
Non-invasive localized positive electrostatic therapy of malignant cancer tumors by suppression of anti-apoptotic enzymes and expression of apoptotic ones and investigation of its effects on malignant tumors.
Design
Patients are recommended by their specialist to enter the study and the patch of electrostatic therapy is placed on their skin. We are prepared to take 50 patients at the hospital and apply Electrostatic therapy on them. Patients are aware of their treatment.
Settings and conduct
The patients who candidate for study, hospitalize at the Noorafshar hospital. The size of the tumors, tumor markers and other serum markers is measured before the therapy. The patch is placed on the surface of the patient's skin at the nearest place to the tumor and fixes there. Patients can detach the device for personal stuffs and attach it again. They hospitalize for about 12 days and during these days vital sign is checked per 6 hours and other general assessment per 12 hours. After the end of the course, the sizes and blood markers are checked again and announced to the specialists.
Participants/Inclusion and exclusion criteria
Patients who have malignant solid tumors with high proliferation factor.The cells are not obey the normal cellular pathway of the tissue.
Intervention groups
We use a flexible patch which is designed by nano fabrication process, charged by DC electrical power system 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 tumor. The size of the tumors are compared with the ones which are outside of the patch's area.
Main outcome variables
Changes of tumors' size, alteration in microscopic and pathological characteristics and IHC markers of the tumor, changes in clinical manifestations, Changes of different serum markers and electrolytes.
General information
Reason for update
Acronym
ECT
IRCT registration information
IRCT registration number:IRCT20190904044697N2
Registration date:2019-11-02, 1398/08/11
Registration timing:registered_while_recruiting
Last update:2019-11-02, 1398/08/11
Update count:0
Registration date
2019-11-02, 1398/08/11
Registrant information
Name
Mohammad Abdolahad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8367
Email address
m.abdolahad@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-01, 1397/10/11
Expected recruitment end date
2020-01-01, 1398/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Non-invasive localized positive electrostatic therapy of malignant cancer tumors by suppression of anti-apoptotic enzymes and expression of apoptotic ones
Public title
Positive Electrostatic therapy; selective destruction of cancer tumors through their attraction to positive charges
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
0
In patients who have at least 2 tumors which have appropriate distance from each other, one of them are treated (intervention) and the other one consider to be the control tumor.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
No.23, 16 Azar Ave, Tehran Ave., Tehran, Iran Postal Code: 1417863181
City
Tehran
Province
Tehran
Postal code
1417863181
Approval date
2018-08-18, 1397/05/27
Ethics committee reference number
IR.TUMS.VCR.REC.1397.354
Health conditions studied
1
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
2
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C78.7
ICD-10 code description
Secondary malignant neoplasm of liver and intrahepatic bile duct
3
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C77
ICD-10 code description
Secondary and unspecified malignant neoplasm of lymph nodes
4
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C78.0
ICD-10 code description
Secondary malignant neoplasm of lung
5
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C79.2
ICD-10 code description
Secondary malignant neoplasm of skin
6
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C73
ICD-10 code description
Malignant neoplasm of thyroid gland
7
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C83.3
ICD-10 code description
Diffuse large B-cell lymphoma
8
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C22.1
ICD-10 code description
Intrahepatic bile duct carcinoma
9
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C56
ICD-10 code description
Malignant neoplasm of ovary
10
Description of health condition studied
Malignant cancer with solid tumor
ICD-10 code
C48.2
ICD-10 code description
Malignant neoplasm of peritoneum, unspecified
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
Quality Of Life
Timepoint
90 days
Method of measurement
Questionnaire about quality of life indicators based on EORTC QLQ-C30
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Treatment - Devices
3
Description
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.
No. 38, West Nastaran Ave (Arab), Khorramshahr St., North Sohrevardi St., Tehran
City
Tehran
Province
Tehran
Postal code
1533984611
Phone
+98 21 8876 9188
Email
info@nanofund.ir
Web page address
http://nanofund.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Nano Fund
Proportion provided by this source
70
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Abdolahad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
electrotechnical Specialist in oncosurgery and cancer therapy
Street address
Nano bio electronic lab, ground floor, school of electrical and computer engineering, university of Tehran faculty of engineering, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1439957131
Phone
+98 21 8802 8367
Email
m.abdolahad@ut.ac.ir
Web page address
https://nbel.ut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Abdolahad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cancer Specialist
Street address
Nano bio electronic lab, ground floor, school of electrical and computer engineering, university of Tehran faculty of engineering, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1439957131
Phone
+98 21 8802 8367
Email
m.abdolahad@ut.ac.ir
Web page address
https://nbel.ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Abdolahad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cancer Specialist
Street address
Nano bio electronic lab, ground floor, school of electrical and computer engineering, university of Tehran faculty of engineering, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1439957131
Phone
+98 21 8802 8367
Email
m.abdolahad@ut.ac.ir
Web page address
https://nbel.ut.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
60% of the information about the main outcome, can be shared
When the data will become available and for how long
Available 6 months after the paper has been published.
To whom data/document is available
The data will be available for medical staff and academic institutions.
Under which criteria data/document could be used
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
From where data/document is obtainable
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.
What processes are involved for a request to access data/document