Ameliorative effect of curcumin on intestinal complications of colorectal cancer chemoradiation: a randomized, double-blind, placebo-controlled study.
Design
a randomized, double-blinded, placebo-controlled study in 56 patients
Settings and conduct
This double-blind, randomized clinical trial study was conducted using a placebo in the radiation therapy department of Omid Hospital in Isfahan (Seyd Al-Shahada). Random allocation was done by a third person (outside the study) and by systematic randomization. For the purpose of blinding, neither the participant in the research nor the leading researcher (physician) knew about the random allocation and drug or placebo in the capsule delivered to the patient, and only the third person (outside the study) knew the drug and placebo.
Participants/Inclusion and exclusion criteria
Rectal cancer in sage II-III which needs chemoradiation
Intervention groups
Curcumin
Placebo
Main outcome variables
Decrease of bowel complications including diarrhea, bowel obstruction, abdominal pain, or blood in the stool
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220429054699N1
Registration date:2023-10-19, 1402/07/27
Registration timing:retrospective
Last update:2023-10-19, 1402/07/27
Update count:0
Registration date
2023-10-19, 1402/07/27
Registrant information
Name
Ali Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3771 4881
Email address
aalliiee50@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-05, 1396/01/16
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
2017-04-05, 1396/01/16
Actual recruitment end date
2018-03-06, 1396/12/15
Trial completion date
2018-04-09, 1397/01/20
Scientific title
Improving effect of Curcumin on Chemoradiotherapy-Induced Enteritis of colorectal cancer: a randomized, double-blinded, placebo-controlled study
Public title
Improving effect of Curcumin on Chemoradiotherapy-Induced Enteritis of colorectal cancer: a randomized, double-blinded, placebo-controlled study
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Rectal cancer
Indication of chemo-Radiation
Exclusion criteria:
Hypersensitivity to traumatic
Age
From 20 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
56
Actual sample size reached:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Since this study is a double-blind clinical trial neither the main researcher nor the participants should know about the placement of people in the intervention and control groups.
Therefore, in this study, a third person (outside the study) was asked to divide the selected people into two groups of the same size using random allocation software v.2.
In this way, first, the list of people eligible to enter the study is entered into the random allocation software, the number of groups is defined for the software (2 groups, intervention, and control), and the sample size of each group is also entered (n=28). The software randomly assigns the samples to 2 groups with the same sample size, and the list of people in the two groups is kept by a third party (outside the study).
Blinding (investigator's opinion)
Double blinded
Blinding description
Since this study is double-blind, neither the main researcher nor the participants knew about the placement of the samples in the intervention categories. The intervention was done by a third person outside the study. Necessary explanations were given to them by the main researcher. The medicine capsule and placebo (formula) were completely identical in terms of size, shape and color, and only the third person (outside the study and having expertise in the field of study) knew whether it was a medicine or not. The first group (intervention) was given 500 mg curcumin daily and the control group (placebo) was given a similar capsule without medicine. Every two weeks, demographic information and clinical symptoms and signs of enterocolitis of both groups were collected by a third person and provided to the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8188633111
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
IR.MUI.REC.1396.3.588
Health conditions studied
1
Description of health condition studied
RECTAL CANCER
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
chemo radiation side effect
Timepoint
weekly
Method of measurement
Visiting and filling out the Criteria for Adverse Events of intestinal form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Curcumin is a medicine to reduce inflammation. In this study, we intended to measure its effect on enterocolitis caused by radiation therapy. Therefore, from the first day for 25-28 days (depending on the patients' radiotherapy time), we considered a daily dose of 500 mg (standard curcumin capsules) for people undergoing chemotherapy. The drugs were given to the patients daily at a particular time (how many hours after chemotherapy?). This medicine was taken orally. This drug is a product of Karen Pharmaceuticals and Vital Food Supplements Company. Its ingredients include 500 mg of turmeric extract (475 mg of curcuminoids).
Category
Treatment - Drugs
2
Description
Control group: We used a capsule similar to the main drug (placebo) in the control group. This group also received a daily capsule similar to the intervention group. The treatment duration and consumption method were identical to the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
seyed al shohada hospital
Full name of responsible person
Ali Ebrahimi
Street address
Motahari Street
City
Isfahan
Province
Isfehan
Postal code
8188633111
Phone
+98 31 3235 9545
Email
aalliiee50@yahoo.com
Web page address
https://omid.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nadia Najafizadeh
Street address
Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8188633111
Phone
+98 31 3668 0048
Email
aalliiee50@yahoo.com
Web page address
https://mail.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Ebrahimi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
motahari street
City
Isfahan
Province
Isfehan
Postal code
8188633111
Phone
+98 913 308 0828
Email
aalliiee50@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nadia Najafizahe
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Motahari Street
City
Isfahan
Province
Isfehan
Postal code
8188633111
Phone
+98 31 3235 0214
Email
aalliiee50@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Ebrahimi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Motahari Street
City
Isfahan
Province
Isfehan
Postal code
8188633111
Phone
+98 913 308 0828
Email
aalliiee50@yahoo.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
number of side effects
When the data will become available and for how long
of 2018
To whom data/document is available
Researchers
Under which criteria data/document could be used
all kinds of analysis
From where data/document is obtainable
Seyed alshohada Hospital
What processes are involved for a request to access data/document
The phone call is then approved by the researcher and the ethics committee