학술논문
A randomized, double-blind, placebo-controlled investigation of BCc1 nanomedicine effect on survival and quality of life in metastatic and non-metastatic gastric cancer patients
Document Type
article
Author
Maryam Hafizi; Somayeh Kalanaky; Hassan moaiery; Maryam Khayamzadeh; Sajad Noorian; Vahid Kaveh; Behrooz Gharib; Hossein Foudazi; Mohsen Razavi; Arash Jenabian; Saeid Salimi; Mohammad Mahdi Adib Sereshki; Hamid Reza Mirzaei; Afshin Zarghi; Saideh Fakharzadeh; Mohammad Hassan Nazaran; Mohammad Esmaeil Akbari
Source
Journal of Nanobiotechnology, Vol 17, Iss 1, Pp 1-19 (2019)
Subject
Language
English
ISSN
1477-3155
Abstract
Abstract Background Currently, the main goal of cancer research is to increase longevity of patients suffering malignant cancers. The promising results of BCc1 in vitro and vivo experiments made us look into the effect of BCc1 nanomedicine on patients with cancer in a clinical trial. Methods The present investigation was a randomized, double-blind, placebo-controlled, parallel, and multicenter study in which 123 patients (30-to-85-year-old men and women) with metastatic and non-metastatic gastric cancer, in two separate groups of BCc1 nanomedicine or placebo, were selected using a permuted block randomization method. For metastatic and non-metastatic patients, a daily dose of 3000 and 1500 mg was prescribed, respectively. Overall survival (OS) as the primary endpoint and quality of life (measured using QLQ-STO22) and adverse effects as the secondary endpoints were studied. Results In metastatic patients, the median OS was significantly higher in BCc1 nanomedicine (174 days [95% confidence interval (CI) 82.37–265.62]) than in placebo (62 days [95% CI 0–153.42]); hazard ratio (HR): 0.5 [95% CI 0.25–0.98; p = 0.046]. In non-metastatic patients, the median OS was significantly higher in BCc1 nanomedicine (529 days [95% CI 393.245–664.75]) than in placebo (345 days [95% CI 134.85–555.14]); HR: 0.324 [95% CI 0.97–1.07; p = 0.066]. The QLQ-STO22 assessment showed a mean difference improvement of 3.25 and 2.29 (p value > 0.05) in BCc1 nanomedicine and a mean difference deterioration of − 4.42 and − 3 (p-value