scholarly journals Nano-drug Clinical Trials: Informed Consent and Risk Management Through Blockchain

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yousef Haik ◽  
Ilias Bantekas
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
New Technologies ◽  
Therapeutic Index ◽  
Drug Carriers ◽  
Recurrent Breast Cancer ◽  
Legal Issues ◽  
Shell Size ◽  
Recurrent Breast ◽  
New Formulation

Drug bearing nano-shells that can be utilized for targeted drug delivery have been shown to enhance the therapeutic index by increasing the dug concentration in diseased tissue and reducing the toxicity in normal tissue.  The controllability of the drug bearing shell size provides predictability measure for the amount of drug payload per shell which improves the administration of the therapeutic dose.  The FDA approved different formulations for clinical use in metastatic and recurrent breast cancer, among other diseases.  At the moment, some of these formulations are the subject of international clinical trials.  Informed consent is legally mandated in administering drug bearing nano-shells.  The risks of the new formulations, as with all new technologies, are not well known and are continue to be a subject of intensive research, thus exacerbating the existing informed consent legal issues, thus exacerbating the existing informed consent legal issues.  This short essay focuses on proposing a framework to mitigate liabilities administering a new formulation on nano-enabled drug carriers particularly when uncertainties of the benefits and damages are not fully known. 

New Enzyme-Targeting Radiosensitizer (KORTUC II) Treatment for Locally Advanced or Recurrent Breast Cancer

2021 ◽  
Author(s):  
Taiju Shimbo ◽  
Mio Nakata ◽  
Hiroto Yoshioka ◽  
Chikara Sato ◽  
Akihiro Hori ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hydrogen Peroxide ◽  
Clinical Trials ◽  
Irradiation Dose ◽  
Locally Advanced ◽  
Sodium Hyaluronate ◽  
Recurrent Breast Cancer ◽  
Tumor Control ◽  
Recurrent Breast ◽  
Clinical Trials Registry

Abstract PurposeKochi Oxydol-Radiation Therapy for Unresectable Carcinomas II (KORTUC II) is currently the most widely used radiosensitizer in clinical use in Japan. Its use sensitizes tumors to radiation by injecting hydrogen peroxide into the tumors to neutralize antioxidant enzymes and, simultaneously, increase intratumor oxygen tension. KORTUC II has achieved significant local effects with no notable adverse events. We report on the cases where KORTUC II was used to treat patients with locally advanced breast cancer (LABC) or recurrent breast cancer (LRBC).Methods and MaterialsThirty patients treated with KORTUC II for LABC (n = 9) or LRBC (n = 21), who were followed up for at least 3 months after treatment, were included in the study. This sensitizer is a solution consisting of 0.83% sodium hyaluronate and 0.5% hydrogen peroxide by volume. The mixture was injected intratumorally several times during the treatment period under ultrasound guidance, just before RT doses. RT was administered for local control. The irradiation dose and extent fields were determined by the attending physicians considering patient factors. Maximum tumor shrinkage (MTS) was measured by Computed Tomography. The duration of loco-regional control (LC) and progression free survival (PFS) after the completion of RT were determined using the Kaplan–Meier method.ResultsThe median irradiation dose was 60.4 Gy3.5 (43.6–76.1 Gy3.5) based on the calculation of EQD2, and median total number of sensitizer treatments was 5 (2–7). The median MTS was 97.0%. Fifteen patients (50%) were assessed to have achieved a clinical complete response. The proportion of patients with LC at 1, 2, and 3 years was 100%, 94.7%, and 75.4%. The proportion with PFS after RT at 1 and 2 years was 59.0%, and 24.1%, respectively.ConclusionsKORTUC II treatment demonstrated high rates of local tumor control for LABC and LRBC. KORTUC II is expected to be an inexpensive and extremely promising RT with an excellent radio-sensitizing effect.Trial registrationOsaka Medical College Clinical Trials Registry, trial no. 1973, date. May 10, 2010UMIN Clinical Trials Registry, trial no. UMIN000003734, date. June 10, 2010

scholarly journals Debulking mastectomy with electrochemotherapy: a case report of no surgery approach to recurrent breast cancer.

2020 ◽  
Author(s):  
Emanuela Esposito ◽  
Claudio Siani ◽  
Ugo Pace ◽  
Raffaele Costanzo ◽  
Raimondo di Giacomo
Keyword(s):  
Breast Cancer ◽  
Chest Wall ◽  
New Technologies ◽  
Cancer Recurrence ◽  
Recurrent Breast Cancer ◽  
Breast Conserving Surgery ◽  
Breast Cancer Recurrence ◽  
Multi Drug Resistance ◽  
Patient Will ◽  
Recurrent Breast

Abstract Background Electrochemotherapy has been shown to be safe, effective and non-invasive loco-regional treatment for chest wall breast cancer recurrence. Electrochemotherapy is the gold standard treatment of patients with cutaneous metastases from breast cancer who due to the extent of those lesions are not eligible for resection or radiotherapy has already been used, and systemic therapy is ineffective or contraindicated. Case presentation Here we present the case of a women affected by multiple metastatic cancers with multi-drug resistance who refused mastectomy after being diagnosed with recurrent ulcerated right breast cancer. We first describe an extended indication to electrochemotherapy to treat breast cancer recurrence after breast conserving surgery. Electroporation-induced necrosis through electrochemotherapy replaced surgery and was delivered in 30 minutes at 5000 Hz frequencies at 730 V by hexagonal needle under general anesthesia. The necrosis of the remaining breast resulted in a voluminous eschar that was easily removed few months after leaving the chest wall free from macroscopic disease turning in a non-surgical mastectomy. Conclusions. This kind of breakthrough application of electrochemotherapy might be considered to avoid palliative mastectomy in very selected patients. New technologies may help clinicians to find agreement between patient’ will and the burden of treatment and might contribute in selected cases to give options to patients not keen on having surgery.

ER, PR & HER2 Receptor status in recurrent breast cancer: Its relation to age & time of recurrence

2020 ◽  
Vol 22 (1) ◽  
pp. 16-20
Author(s):  
Abu Khaled Muhammad Iqbal ◽  
Nasima Akhter ◽  
Hasan Shahrear Ahmed ◽  
Md Rassell ◽  
AMM Yahia ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Approach ◽  
Recurrent Breast Cancer ◽  
Breast Cancer Patients ◽  
Her2 Receptor ◽  
Younger Patients ◽  
Receptor Status ◽  
Increased Risk ◽  
Neoplastic Lesions ◽  
Recurrent Breast

Background: Malignant neoplastic lesions of the breast are one of the main causes of cancer death among women. In tumor cells the expression status of Estrogen receptor (ER), progesterone receptor (PR), and c-ERBB2 (HER2/neu) are therapeutically and prognostically important markers affecting the treatment approach, management and prognosis of breast carcinoma. Objective: To explore the relation of receptor status in recurrent breast cancer to age and time of recurrence. Methods: This study was conducted in National Institute of Cancer Research and Hospital (NICRH) and included 81 female patients between 20 to 75 years with recurrent breast cancer. Detection of receptor status of ER +ve/-ve, PR +ve/-ve, Her-2+ve/-ve was based on the immunohistochemistry staining of tissue samples of malignant neoplastic lesions prepared from tissue biopsies of patients with recurrent breast cancer. All the information were recorded through the pre-structured data collection sheet and analyzed. Results: This study showed that most of the recurrent breast cancer patients were Triple negative breast cancer (TNBC) (39.5%) and among them most of them were younger patients. Younger patients with TNBC had increased risk of recurrence. Most of the recurrence occurred within 1-2 years. Conclusion: It can be concluded that the assessment of the expression of these biornarkers in recurrent tumors provides reliable information for the treatment approach of locoregional tumors. Journal of Surgical Sciences (2018) Vol. 22 (1): 16-20

Clinical trials — the personal perspective of the research physician?

2020 ◽  
Vol 75 (3) ◽  
pp. 256-263
Author(s):  
Maria Y. Egorova ◽  
Irina A. Shuvalova ◽  
Olga I. Zvonareva ◽  
Igor D. Pimenov ◽  
Olga S. Kobyakova ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Care ◽  
New Technologies ◽  
Healthcare Providers ◽  
Study Drug ◽  
Well Being ◽  
Personal Perspective ◽  
Public And Private ◽  
Factors Affecting ◽  
To Receive

Background. The organization of clinical trials (CTs) requires the participation and coordination of healthcare providers, patients, public and private parties. Obstacles to the participation of any of these groups pose a risk of lowering the potential for the implementation of CTs. Researchers are a key human resource in conducting of CT. Their motivation for participation can have a significant impact on the recruitment and retention of patients, on the quality of the data collected, which determines the overall outcome of the study. Aims to assess the factors affecting the inclusion of Russian physicians-researchers in CT, and to determine their role in relations with patients-participants. Materials and methods. The study was organized as a part of the Russian multicenter face-to-face study. A survey was conducted of researchers from 10 cities of Russia (20172018). The participation in the survey for doctors was anonymous and voluntary. Results. The study involved 78 respondents. Most research doctors highly value the importance of research for science (4,84 0,39), society (4,67 0,46) and slightly lower for participating patients (4,44 0,61). The expectations of medical researchers are related to improving their financial situation and attaining new experience (n = 14; 18,18%). However, the opportunity to work with new technologies of treatment and diagnosis (n = 41; 52,56%) acted as a motivating factor. According to the questionnaire, the vast majority of research doctors (n = 29; 37,18%) believe that the main reason for patients to participate in CT is to receive quality and free medical care. The most significant obstacle to the inclusion of participants in CT was the side effects of the study drug (n = 38; 48,71%). Conclusions. The potential of clinical researchers in Russia is very high. The patient-participant acts for the research doctor as the subject of the study, and not the object, so the well-being of the patient is not indifferent to the doctor. However, the features of the functioning of our health care system form the motivation of doctors-researchers (additional earnings, professional self-development) and the way they perceive the motivation of patients (CT as an opportunity to receive quality medical care).

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