Evidence map›Paper›PMID 30971278›Full record

Trial reportJournal of nanobiotechnology2019

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.

Maryam Hafizi, Somayeh Kalanaky, Hassan Moaiery, Maryam Khayamzadeh, Sajad Noorian, Vahid Kaveh, Behrooz Gharib, Hossein Foudazi, Mohsen Razavi, Arash Jenabian and 7 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of nanobiotechnology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Maryam HafiziCancer Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Somayeh KalanakyDepartment of Research and Development, Sodour Ahrar Shargh Company, Tehran, Iran.
Hassan MoaieryCancer Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Maryam KhayamzadehCancer Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Sajad NoorianDepartment of Statistics, Faculty of Sciences, University of Qom, Qom, Iran.
Vahid KavehFirouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran.
Behrooz GharibNaft Company Hospital, Tehran, Iran.
Hossein FoudaziShahid Fayaz-Bakhsh Hospital, Tehran, Iran.
Mohsen RazaviFirouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran.
Arash JenabianDepartment of Medical Oncology and Hematology, Tehran Medical Sciences Branch, Islamic Azad University, Tehran, Iran.
Saeid SalimiFirouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran.
Mohammad Mahdi Adib SereshkiFirouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran.
Hamid Reza MirzaeiCancer Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Afshin ZarghiDepartment of Medicinal and Pharmaceutical Chemistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Saideh FakharzadehDepartment of Research and Development, Sodour Ahrar Shargh Company, Tehran, Iran.
Mohammad Hassan NazaranDepartment of Research and Development, Sodour Ahrar Shargh Company, Tehran, Iran. mnazaran@nanochelatingtechnology.com.
Mohammad Esmaeil AkbariCancer Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran. crc@sbmu.ac.ir.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrently, 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.

methodsThe 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.

resultsIn 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.

conclusionThe 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.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAnimalsDisease-Free SurvivalDouble-Blind MethodFemaleHumansMaleMiddle AgedNanocompositesNanomedicineNeoplasm MetastasisPain ManagementProportional Hazards ModelsBCc1 nanomedicineCancerClinical trialGastric cancerNanochelating technologyNanomedicine

Identifiers

PMID30971278
PMCPMC6458717

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.