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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

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 in...

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Autores principales: Hafizi, Maryam, Kalanaky, Somayeh, moaiery, Hassan, Khayamzadeh, Maryam, Noorian, Sajad, Kaveh, Vahid, Gharib, Behrooz, Foudazi, Hossein, Razavi, Mohsen, Jenabian, Arash, Salimi, Saeid, Sereshki, Mohammad Mahdi Adib, Mirzaei, Hamid Reza, Zarghi, Afshin, Fakharzadeh, Saideh, Nazaran, Mohammad Hassan, Akbari, Mohammad Esmaeil
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6458717/
https://www.ncbi.nlm.nih.gov/pubmed/30971278
http://dx.doi.org/10.1186/s12951-019-0484-0
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author Hafizi, Maryam
Kalanaky, Somayeh
moaiery, Hassan
Khayamzadeh, Maryam
Noorian, Sajad
Kaveh, Vahid
Gharib, Behrooz
Foudazi, Hossein
Razavi, Mohsen
Jenabian, Arash
Salimi, Saeid
Sereshki, Mohammad Mahdi Adib
Mirzaei, Hamid Reza
Zarghi, Afshin
Fakharzadeh, Saideh
Nazaran, Mohammad Hassan
Akbari, Mohammad Esmaeil
author_facet Hafizi, Maryam
Kalanaky, Somayeh
moaiery, Hassan
Khayamzadeh, Maryam
Noorian, Sajad
Kaveh, Vahid
Gharib, Behrooz
Foudazi, Hossein
Razavi, Mohsen
Jenabian, Arash
Salimi, Saeid
Sereshki, Mohammad Mahdi Adib
Mirzaei, Hamid Reza
Zarghi, Afshin
Fakharzadeh, Saideh
Nazaran, Mohammad Hassan
Akbari, Mohammad Esmaeil
author_sort Hafizi, Maryam
collection PubMed
description 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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spelling pubmed-64587172019-04-19 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 Hafizi, Maryam Kalanaky, Somayeh moaiery, Hassan Khayamzadeh, Maryam Noorian, Sajad Kaveh, Vahid Gharib, Behrooz Foudazi, Hossein Razavi, Mohsen Jenabian, Arash Salimi, Saeid Sereshki, Mohammad Mahdi Adib Mirzaei, Hamid Reza Zarghi, Afshin Fakharzadeh, Saideh Nazaran, Mohammad Hassan Akbari, Mohammad Esmaeil J Nanobiotechnology Research 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. BioMed Central 2019-04-10 /pmc/articles/PMC6458717/ /pubmed/30971278 http://dx.doi.org/10.1186/s12951-019-0484-0 Text en © The Author(s) 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Hafizi, Maryam
Kalanaky, Somayeh
moaiery, Hassan
Khayamzadeh, Maryam
Noorian, Sajad
Kaveh, Vahid
Gharib, Behrooz
Foudazi, Hossein
Razavi, Mohsen
Jenabian, Arash
Salimi, Saeid
Sereshki, Mohammad Mahdi Adib
Mirzaei, Hamid Reza
Zarghi, Afshin
Fakharzadeh, Saideh
Nazaran, Mohammad Hassan
Akbari, Mohammad Esmaeil
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort randomized, double-blind, placebo-controlled investigation of bcc1 nanomedicine effect on survival and quality of life in metastatic and non-metastatic gastric cancer patients
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6458717/
https://www.ncbi.nlm.nih.gov/pubmed/30971278
http://dx.doi.org/10.1186/s12951-019-0484-0
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