Non-invasive and local treatment of breast tumors using targeted drug delivery with charged or water-soluble drugs and increase their uptake by opposite electrostatic charge
Design
Patients are recommended by their specialist to enter the study, and after chemotherapy started, the patch of electrostatic therapy (by opposite charge) is placed on their skin.
We are prepared to admit 40 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 motamed center institute breast cancer research center. The size of the tumors, tumor markers and other serum markers is measured before and after the therapy and announce to specialist. The patch is placed on the surface of the patient's skin at the nearest place to the tumor during chemotherapy and fixes there. Patients can detach the device for personal stuffs and attach it again; during these days vital sign is checked per 6 hours and other general assessment per 12 hours.
Participants/Inclusion and exclusion criteria
Patients with breast cancer who have a distinct mass from the surrounding tissue and are candidates for chemotherapy.
Intervention groups
In this study, patients are candidate and treated for EDD according to the inclusion criteria. After injection of the polar or water-soluble drug, the flexible patch, which is made using nanotechnology and is charged by a direct current electric power supply, is placed on the surface closest to the mass on the body and fixed during chemotherapy treatment. Mass changes in the patch area are compared to out-of-area masses.
Main outcome variables
Changes of tumors' size in EDD method, 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
EDD
IRCT registration information
IRCT registration number:IRCT20190904044697N6
Registration date:2020-09-14, 1399/06/24
Registration timing:registered_while_recruiting
Last update:2020-09-14, 1399/06/24
Update count:0
Registration date
2020-09-14, 1399/06/24
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
2020-01-01, 1398/10/11
Expected recruitment end date
2020-12-29, 1399/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Targeted drug delivery using polar or charged drugs by opposite electrostatic charge, in breast cancer clinical trial
Public title
Targeted polar or charged drug delivery, using opposite electrostatic charge
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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, adjutantو and post-operative circumstance.
Patients who are indicated for administration polar water-soluble or charged chemotherapy drugs such as cisplatin, carboplatib, cyclophosphamide, doxorubicin
Exclusion criteria:
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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
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
Parallel
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.
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
2020-01-31, 1398/11/11
Ethics committee reference number
IR.TUMS.VCR.REC.1398.852
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
Drug delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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.
2
Description
Serum tumor marker
Timepoint
10 days after the first, second, third, and fourth courses of chemotherapy
Method of measurement
laboratory test on blood samples
3
Description
Clinical Manifestations
Timepoint
10 days after the first, second, third, and fourth courses of chemotherapy
Method of measurement
Accurate history taking and physical examination
4
Description
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
5
Description
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
Secondary outcomes
1
Description
Quality Of Life
Timepoint
90 days
Method of measurement
Questionnaire about quality of life indicators based on EORTC QLQ-C30
2
Description
evaluating long side effects of chemotherapy drugs
Timepoint
90 days
Method of measurement
history taking and physical examination
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motamed Cancer Institute, Breast Cancer Center
Full name of responsible person
Dr Mohammad Abdolahad
Street address
Motamed Cancer Institute, No.146, South Gandi Ave, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8887 6869
Fax
+98 21 8879 6208
Email
Info@ibcrc.ir
Web page address
http://ibcrc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran Nano Fund
Full name of responsible person
Dr Mohammad Hosein Bahreini
Street address
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tehran University of Medical Sciences
Position
Dr Mohammad Abdolahad
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
Breast cancer surgery
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
Breast cancer surgery
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