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J Nanobiotechnology. 2019 Apr 10;17(1):52. doi: 10.1186/s12951-019-0484-0.

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.

Author information

1
Cancer Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
2
Department of Research and Development, Sodour Ahrar Shargh Company, Tehran, Iran.
3
Department of Statistics, Faculty of Sciences, University of Qom, Qom, Iran.
4
Firouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran.
5
Naft Company Hospital, Tehran, Iran.
6
Shahid Fayaz-Bakhsh Hospital, Tehran, Iran.
7
Department of Medical Oncology and Hematology, Tehran Medical Sciences Branch, Islamic Azad University, Tehran, Iran.
8
Department of Medicinal and Pharmaceutical Chemistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
9
Department of Research and Development, Sodour Ahrar Shargh Company, Tehran, Iran. mnazaran@nanochelatingtechnology.com.
10
Cancer Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran. crc@sbmu.ac.ir.

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 < 0.05) in placebo with metastatic and non-metastatic patients, respectively. No adverse effects were observed.

CONCLUSION:

The findings of this trial has provided evidence for the potential capacity of BCc1 nanomedicine for treatment of cancer. Trial registration IRCTID, IRCT2017101935423N1. Registered on 19 October 2017, http://www.irct.ir/ IRCT2017101935423N1.

KEYWORDS:

BCc1 nanomedicine; Cancer; Clinical trial; Gastric cancer; Nanochelating technology; Nanomedicine

PMID:
30971278
PMCID:
PMC6458717
DOI:
10.1186/s12951-019-0484-0
[Indexed for MEDLINE]
Free PMC Article

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