Study of the potential radioprotective effects of probiotic bacteria to mitigate gastrointestinal complications of colorectal cancer after conventional radiotherapy
Evaluation of the effect of probiotic bacteria on quality of life, blood factors and reduction of gastrointestinal complications after conventional radiotherapy procedures in patients with colorectal cancer
Design
This is a double-blind randomized clinical trial study. Randomization will be done by computer software. 60 patients with colorectal cancer will be selected in the study. Patients will be divided to receive probiotic supplements or placebo.
Settings and conduct
This clinical trial will be performed in the oncology radiotherapy unit of Namazi Hospital in Shiraz. Patients with colorectal cancer will be divided in one of the probiotic or placebo groups.
Participants/Inclusion and exclusion criteria
Admission criteria are adults who have colorectal cancer (colon and rectum) and will be treated with radiotherapy and their age is 18 to 90 years. Exclusion criteria include the use of narcotic analgesics, acute and chronic gastrointestinal complications before treatment, use of any antibiotics in a week before the start of radiotherapy unless prescribed by a doctor, dissatisfaction with continued treatment, non-adherence to the treatment regimen, Do not use any probiotic supplements, including probiotic yogurt for 15 days before starting treatment, do not use anti-diarrheal drugs (unless prescribed by a doctor) and do not receive radiation therapy in the abdomen and pelvis in previous years.
Intervention groups
Group 1: 2 probiotic capsules daily from one week before the start of treatment to ten days after the end of treatment
Group 2: 2 probiotic capsules daily from one week after the start of treatment to ten days after the end of treatment
Group 3: 2 probiotic placebo capsules daily
Main outcome variables
Quality of life, Gastrointestinal symptoms, Blood factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210704051788N1
Registration date:2021-10-10, 1400/07/18
Registration timing:prospective
Last update:2021-10-10, 1400/07/18
Update count:0
Registration date
2021-10-10, 1400/07/18
Registrant information
Name
Hamidreza Jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 9332
Email address
jamalihamidreza91@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-12, 1400/07/20
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the potential radioprotective effects of probiotic bacteria to mitigate gastrointestinal complications of colorectal cancer after conventional radiotherapy
Public title
Study of the potential radioprotective effects of probiotic bacteria to mitigate gastrointestinal complications after conventional radiotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults with colorectal cancer who are candidates for radiotherapy as part of their treatment
Exclusion criteria:
Consumption of narcotic painkillers
Existence of acute and chronic gastrointestinal complications before starting treatment
Take any antibiotics one week before the start to end of radiotherapy
Received radiation therapy in the abdomen and pelvis in recent years
Use probiotic supplements during the 15 days before the study and also take other probiotic forms including probiotic yogurt and other fermented foods
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly assigned to three groups to receive probiotics one week before the start of radiotherapy (n = 20), one week after the start of radiotherapy (n = 20) or placebo (n = 20).
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization will be hidden from researchers and participants until the statistical analysis is completed.Another person who has no role in this clinical trial and is not aware of random allocation gives the capsules to participants.
Placebo
Used
Assignment
Parallel
Other design features
Participants will take probiotics for up to ten days after completing radiotherapy
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences -Zand Blvd
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۱۴۳۳۶
Approval date
2021-09-11, 1400/06/20
Ethics committee reference number
IR.SUMS.REC.1400.457
Health conditions studied
1
Description of health condition studied
Colorectal Cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
2
Description of health condition studied
Colorectal Cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
Quality of life
Timepoint
At the beginning of the study and 8 weeks after the intervention
Method of measurement
Questionnaire
2
Description
Gastrointestinal disorders
Timepoint
At the beginning of the study and 6 months after the intervention
Method of measurement
Clinical examination by an oncologist
Secondary outcomes
1
Description
Thrombocytopenia-Leukopenia-Anemia
Timepoint
At the beginning of the study and 8 weeks after the intervention
Method of measurement
CBC Test(Complete blood count)
Intervention groups
1
Description
Intervention group: 1-Patients will take two capsules (daily) containing several probiotic strains from one week before the start of treatment until 10 days after the end of radiotherapy.
Category
Treatment - Drugs
2
Description
Intervention group: 2-Patients will take two capsules (daily) containing several probiotic strains from one week after the start of treatment to 10 days after the end of radiotherapy.
Category
Treatment - Drugs
3
Description
Control group: Two placebo capsules daily for ten days after the end of radiotherapy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Dr.Hamid Nasrollahi
Street address
Namazi Hospital-Namazi Sq.
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
nemazee_inf@sums.ac.ir
Web page address
https://namazi.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Rezaeianzadeh
Street address
Zand Blvd - Medical School
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
vcrdep@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
22054
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hamidreza Jamali
Position
Master of Medical Physics
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
Department of Medical Physics,7th floor, School of Medicine,Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3234 9332
Email
jamalihamidreza91@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Javad Mortazavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Department of Medical Physics, 7th floor, School of Medicine, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3208 3363
Email
mortazavismj@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamidreza Jamali
Position
Master of Medical Physics
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
Department of Medical Physics,7th floor, School of Medicine,Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3234 9332
Email
jamalihamidreza91@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
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
Title and more details about the data/document
All data can be shared without personal information
When the data will become available and for how long
6 months after the publication of the results will be given access
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
All requests will be reviewed by the person in charge of public responses
From where data/document is obtainable
All applicants should send their request to jamalihamidreza91@yahoo.com
What processes are involved for a request to access data/document
Requests will be processed within two weeks and the response will be emailed to the applicant.