Assessment of Black Seed effect on the biomarkers of patients with colorectal cancer.
Design
The study is done in Phase 2 clinical trials with a control group, parallel groups، double-blind and randomized assessment.
Patients with colorectal cancer who have performed colon surgery and they are in stage IIb and III colon cancer, participated in this study. 50 cases in each group of sample and control (in total 100 cases).
Settings and conduct
A study is conducted at Qom Shahid Beheshti Hospital. Patients with colorectal cancer who are undergone surgery will be divided in 2 groups of intervention and control, 100 individuals in each group. Serum bio-markers will be evaluated at the baseline, 3 months following the treatment and the end of treatment due to investigation on probable effect of black seed capsule on decreasing bio-markers level in comparison with conventional therapy. Only the general responsive researcher is aware of the nature of the drugs and by assigning codes 1 and 2 to the drugs, the placebo and the main drug are identified.
Participants/Inclusion and exclusion criteria
entrance condition: Age between 20 and 70 years and achieving the first time chemical therapy after colorectal cancer surgery.
non entrance condition: Warm and dry temperate and Pregnant and lactating women.
Intervention groups
Black seed and placebo capsule, which both of them are in the same shape.
Main outcome variables
cancer antigen 19-9 (CA19-9); Carcino Embryonic Antigen (CEA)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039641N1
Registration date:2018-08-29, 1397/06/07
Registration timing:registered_while_recruiting
Last update:2018-08-29, 1397/06/07
Update count:2
Registration date
2018-08-29, 1397/06/07
Registrant information
Name
Hoda Abolhasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3320 9071
Email address
habolhasani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying of Black Seed effect as a complementary chemotherapy treatment on biomarkers of patients with colorectal cancer
Public title
Studying of Black Seed effect on colorectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 70 years
Patients who are aware of their colorectal cancer disease
Performing colorectal cancer Surgery
The existence of colorectal cancer-Stage IIb and III
The first time achieving chemical therapy after colorectal cancer surgery
Exclusion criteria:
Warm and dry temperate
Pregnant and lactating women and married women in childbearing age who do not use reliable contraceptive methods
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done based on block randomization method, and the block size in this study will be 4.
Blinding (investigator's opinion)
Double blinded
Blinding description
The main drug and placebo are quite similar. Only the original researcher is aware of the nature of the drugs and by assigning codes 1 and 2 to the drugs, the placebo and the main drug are identified
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research of Qom University of Medical Sciences
Street address
No. 83, Alley No. 4, Alley 1/1, Safashahr Street
City
Qom
Province
Ghoum
Postal code
3716987366
Approval date
2018-05-01, 1397/02/11
Ethics committee reference number
IR.MUQ.REC.1397.15
Health conditions studied
1
Description of health condition studied
Colorectal cancer
ICD-10 code
C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction
2
Description of health condition studied
colon cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
3
Description of health condition studied
rectum cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
cancer antigen 19-9 (CA19-9)
Timepoint
Baseline, 3 months following the treatment and the end of treatment
Method of measurement
Blood test
2
Description
Carcino Embryonic Antigen (CEA)
Timepoint
Baseline, 3 months following the treatment and the end of treatment
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
500 mg of black seed capsule, at a dose of 1000 mg three times a day in combination with drugs of chemical therapy for patients in treatment group. The duration of treatment with black seed capsule is 6 month.
Category
Treatment - Drugs
2
Description
Control group: placebo is capsule as the same shape and color as black seed capsule in combination with chemotherapy drugs , three times a day for 6 month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز آموزشی درمانی شهید بهشتی
Full name of responsible person
طلیعه ملاباشی
Street address
بلوار شهید بهشتی
City
qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Fax
+98 25 3612 2855
Email
hodaabolhasani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
حسین ثقفی
Street address
No. 83, Alley 4, Alley 1/1, Safashahr St.
City
qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3285 2720
Fax
+98 25 3285 8464
Email
hodaabolhasani@gmail.com
Web page address
http://res.muq.ac.ir/index.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hoda Abolhasani
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medicinal Chemistry
Street address
Pharmacology group, medicin faculty, Ghoum pardis university of medical sciences
City
Ghoum
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3320 9071
Email
hodaabolhasani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Davoud Ouladdameshghi
Position
Assistance Professor
Latest degree
Subspecialist
Other areas of specialty/work
Oncology
Street address
Shaheed Beheshti Blvd
City
Ghoum
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
dodameshghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hoda Abolhasani
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medicinal Chemistry
Street address
Pharmacology group, medicin faculty, Ghoum pardis university of medical sciences
City
Ghoum
Province
Ghoum
Postal code
3716985598
Phone
+98 25 3320 9071
Email
hodaabolhasani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After receiving the results of the study, there are plans to publish the article in valid journals
When the data will become available and for how long
all the time
To whom data/document is available
Depending on the journal in which the study is published
Under which criteria data/document could be used
After receiving the results of the study, there are plans to publish the article in valid journals
From where data/document is obtainable
Depending on the journal in which the study is published
What processes are involved for a request to access data/document
Depending on the journal in which the study is published