Evaluation of the therapeutic effect of crocin along with standard regimes in patients with colorectal cancer, A double blind randomized controlled trial
Evaluation of the therapeutic effect of crocin along with standard regimes in patients with colorectal cancer, A double blind randomized controlled trial
Design
A double blind randomized controlled trial
Randomization Method: Random allocation rule
Sample size: 100
Phase: 3
Settings and conduct
Study population are patients with metastatic colon cancer who were referred to Oncology centers in Mashhad. The treatment regime of participants will be according to the oncologist's opinion according to standard protocols. For intervention group taking Crocin pills will be also added to this regime. Patients will be randomly divided into two groups according to age, sex, stage of disease, etc.: The first group will receive standard treatment with placebo and the second group will receive standard treatment with Crocin pill. The daily dose of crocin will be 30 mg (two 15 mg tablets) for 12 weeks. The Sample size in this study is 100 patients (50 in each group).
Participants/Inclusion and exclusion criteria
The participants studied will be patients with metastatic colon cancer
Colorectal cancer patients with lung or liver metastasis or both that is measurable
Colorectal cancer patients who have not received any chemotherapy for metastasis
Not having the history of any allergy to saffron or its products
Intervention groups
Crocin along with standard regime will be assigned to intervention group.
Main outcome variables
overall survival
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131017015044N2
Registration date:2020-01-12, 1398/10/22
Registration timing:registered_while_recruiting
Last update:2020-01-12, 1398/10/22
Update count:0
Registration date
2020-01-12, 1398/10/22
Registrant information
Name
Soodabeh Shahidsales
Name of organization / entity
Cancer research center
Country
Iran (Islamic Republic of)
Phone
+98 51 1846 1518
Email address
shahidsaless@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of crocin along with standard regimes in patients with colorectal cancer, A double blind randomized controlled trial
Public title
Evaluation of the therapeutic effect of crocin along with standard regimes in colorectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Colorectal cancer patients with lung or liver metastasis or both that is measurable
Colorectal cancer patients who have not received any chemotherapy for metastasis
Exclusion criteria:
History of any allergy to saffron or its products
Age
From 20 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule.
This study with a sample size of 100 people, 50 balls for the placebo group and 50 balls for the intervention group are placed in a container and then the balls are randomly selected without replacement.
Blinding (investigator's opinion)
Double blinded
Blinding description
Sequentially numbered, sealed, opaque envelopes.
A random sequence is created by random allocation rule. Then, based on the sample size, 100 envelopes with aluminum foil inside (to prevent ''hot lighting'') are prepared. Each entity in the random sequence is noted on a card and are replaced in numbered envelop. Finally, the envelopes are sealed and placed in boxes, respectively. The envelops are respectively assigned to each participant so the participant's assigned group is revealed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Second Floor, Ghoreishi Building, Daneshgah Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2018-05-09, 1397/02/19
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.013
Health conditions studied
1
Description of health condition studied
colorectal cancer
ICD-10 code
C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction
Primary outcomes
1
Description
Overall survival
Timepoint
One year after the treatment is completed
Method of measurement
Patient follow-up
Secondary outcomes
1
Description
Progression-free survival
Timepoint
During treatment and after it every 3 months
Method of measurement
criteria of Response evaluation criteria in solid tumors
2
Description
Anemia
Timepoint
Before each session of monthly chemotherapy
Method of measurement
laboratory assessment of complete blood count
3
Description
Neutropenia
Timepoint
Before each session of monthly chemotherapy
Method of measurement
laboratory assessment of complete blood count
4
Description
Thrombocytopenia
Timepoint
Before each session of monthly chemotherapy
Method of measurement
laboratory assessment of complete blood count
5
Description
kidney function
Timepoint
Before each session of monthly chemotherapy
Method of measurement
laboratory assessment of BUN and creatinine
6
Description
liver function
Timepoint
Before each session of monthly chemotherapy
Method of measurement
laboratory assessment of SGOT and SGPT
Intervention groups
1
Description
Intervention group: Crocin along with standard regime will be assigned to intervention group. The daily dose of crocin will be 30 mg (two 15 mg tablets) during 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: The treatment regimen is with Folfiri, Folfox or Xelox and also placebo without Targeted therapy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Soodabeh Shahidsales
Street address
Omid Hospital, Alandasht intersection,Koohsangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Fax
+98 51 3842 8622
Email
info@hospitalomid.com
Web page address
http://omid.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Khorasan Razavi, Mashhad, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
presidentoffice@mums.ac.ir
Web page address
https://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Soodabeh Shahidsales
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Omid Hospital, Alandasht intersection, Koohsangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3846 1518
Email
Shahidsaless@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Soodabeh Shahidsales
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
مشهد- خیابان کوهسنگی- میدان الندشت - بیمارستان امید
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3846 1518
Email
Shahidsaless@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Cancer research canter
Full name of responsible person
Soodabeh Shahidsales
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Omid Hospital, Alandasht intersection, Koohsangi Street
City
mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3846 1518
Email
Shahidsaless@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available