Safety and efficacy evaluation of BCc1 nanomedicine designed based on Nanochelating technology on patients with metastatic and non-metastatic Gastric Cancer
Objectives
BCc1 nanomedicine is designed based on the novel Nanochelating technology for the first time. In this study, the Safety and efficacy evaluation of the quality of life of metastatic and non-metastatic patients in the Gastric Cancer is performed.
Design
The target population in this study is 120 patients with metastatic and non-metastatic Gastric Cancer, defined in two separate groups of 60 individuals in each group, in which patients and researchers are not aware of the type of medication or placebo’s intervention and were put in intervention groups based on randomly assigned blocks. This study is a 1.2-phase and multi-centered study.
Study plan
Upon diagnosis of the illness by the oncologist and recording individual, clinical information and performing the necessary explanations, the patient completes the informed consent form and the q22 life quality form. Based on the Block randomization form, the patient is placed in interventional groups based on metastatic or non-metastatic groups. Medications and the life quality form are given to the patient at the end of a 3-week period and the side effects of the drug are recorded on the basis of a standard form by the researcher.
Participants
Exclusion criteria: All patients who have signed informed consent.
Exit Conditions: The patient's unwillingness.
Interventions
The intervention is medication and placebo. For metastatic patients, a daily dose is 3000 mg and non-metastatic patients a daily dose of 1500 mg.
Variables
Main: Assessing the patient's life quality; nanomedicines safety evaluation.
Secondary: survival; Metastasis evaluation in non-metastasis patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101935423N1
Registration date:2017-10-19, 1396/07/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-19, 1396/07/27
Registrant information
Name
Maryam Hafizi
Name of organization / entity
Cancer Research Centre, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 8002
Email address
mhafizi@nanochelatingtechnology.com
Recruitment status
Recruitment complete
Funding source
Cancer Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Sodour Ahrar Shargh Company, Tehran, Iran.
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy evaluation of BCc1 nanomedicine designed based on Nanochelating technology on patients with metastatic and non-metastatic Gastric Cancer
Public title
Safety and efficacy evaluation of BCc1 nanomedicine on patients with Gastric Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with metastatic and non-metastatic Gastric Cancer who have signed the informed consent form.
Exclusion criteria: Patient's declining to continue taking nano-medicines; Witnessing adverse symptoms in the patient after taking the nano-medicines.
Age
From 25 years old to 85 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
A standard quality of life questionnaire for patients with Gastric Cancer EORTC QLQ-STO22
Secondary outcomes
1
Description
Metastasis
Timepoint
10 months after intervention
Method of measurement
Laboratory examinations and abdominal and pelvic CT scans before and after study
2
Description
survive
Timepoint
For metastatic patients 4 months after intervention and for non-metastatic patients 10 months after intervention
Method of measurement
Kaplan-Meier Estimator
Intervention groups
1
Description
Intervention1: BCc1 nanomedicine dosage for non-metastatic patients is 1500 mg/day and for metastatic patients is 3000 mg/day; 3 times daily and every 8 hours; Duration for use of BCc1 nanomedicine for metastatic patients 4 months and non-metastatic patients 10 months after Intervention; Design and synthesis of BCc1 nanomedicine has don by Sodour Ahrar Shargh Knowledge-based Company and packaging by tehrandarou Company.
Category
Treatment - Drugs
2
Description
Intervention 2:
The administration of placebo capsule, which is similar in shape and size to the capsule of the main drug; Placebo dosage for non-metastatic patients is 1500 mg / day; Placebo dosage for metastatic patients is 3000 mg / day; 3 times daily and every 8 hours ; duration of use for metastatic patients 4 months and non-metastatic patients 10 months after intervention ; The placebo packaging has done by Tehrandarou Company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Hamid Reza Mirzaee
Street address
Tajrish Sq, Shohadaye Tajrish Hospital
City
Tehran
2
Recruitment center
Name of recruitment center
Bu-Ali Hospital
Full name of responsible person
Arash Janabian
Street address
Emam Hossein Sq
City
Tehran
3
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Mohsen Razavi
Street address
Behafarin Ave, Valiasr Sq.
City
Tehran
4
Recruitment center
Name of recruitment center
Shahid Fayaz-Bakhsh Hospital Number Two
Full name of responsible person
Hossein Fudazi
Street address
District 18, Khalij-e-Fars Blvd
City
Tehran
5
Recruitment center
Name of recruitment center
Naft Company Hospital
Full name of responsible person
Behroz Gharib
Street address
Sakhayi St, Hafez Ave
City
Tehran
6
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Hassan galaei kho
Street address
Etemadzadeh St, Fatemi Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cancer Research, Training and Prevention Institute
Full name of responsible person
Maryam Khayamzadeh
Street address
Tajrish Sq, Shohadaye Tajrrish Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cancer Research, Training and Prevention Institute