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Targeted polar or charged drug delivery, using opposite electrostatic charge

Not Applicable
Recruiting
Conditions
Condition 1: Malignant cancer with solid tumor. Condition 2: Drug delivery.
Malignant neoplasm of breast
Registration Number
IRCT20190904044697N6
Lead Sponsor
Iran Nano Fund
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
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, adjutant? 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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod
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.
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