Targeted polar or charged drug delivery, using opposite electrostatic charge
- 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
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
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
Name Time Method 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
Name Time Method 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.