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 Electronic supplementary material The online version of this article (10.1186/s12951-019-0484-0) contains supplementary material, which is available to authorized users.

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Background: Nowadays, one criterion to assess the impact of various treatments in cancer patients is the quality of life (QOL), which represents the patients' physical and psychosocial manner. It is already proved that BCc1 nanomedicine enjoys therapeutic behavior in cancer treatment of in vitro, animal, and human studies. Objectives: In the present study, we aimed at investigating the QOL in gastric cancer patients according to the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) questionnaire after treating them with BCc1 nanomedicine synthesized based on nanochelating technology. Methods: A randomized, double-blind, and multicenter study was conducted to investigate the QLQ-STO30 of 60 metastatic (8 weeks after treatment) and 60 non-metastatic (20 weeks after treatment) gastric cancer patients in two separate groups named BCc1 nanomedicine and placebo. Results: In the metastatic patients, the mean difference of overall QLQ-STO30 showed a 2.8-score improvement in BCc1 nanomedicine (P < 0.05) and a 5.2-score decline in placebo (P < 0.05); in non-metastatic patients, it showed a 2.3-score improvement in BCc1 nanomedicine (P > 0.05) and a 3-score decline in placebo (P > 0.05). Conclusions:The results of the study showed that BCc1 nanomedicine improves a number of indices in metastatic and nonmetastatic gastric cancer patients, such as functional domains, symptom scales, and global QOL included in EORTC QLQ-STO30 questionnaire.