The effects of probiotics administration on acute side effects of chemotherapy regimens in gastroesophageal cancer patients
Design
A randomized, parallel, with a control group, double-blinded, phase 3 of 42 patients. Rand software in Excel was used for randomization.
Settings and conduct
In the oncology ward of Rajaie hospital with a standard questionnaire, based CTCAE , double-blinded(patient and researcher)
Participants/Inclusion and exclusion criteria
Patients with gastroesophageal cancer stage 3,4 who had chemotherapy(dcf,folfox)-induced side effects and were older than 18 with first-grade tumor.
Patients with severe systematic disease (such as heart, kidney, and liver) or previously had chemotherapy or were given antibiotics and probiotics were excluded.
Intervention groups
Patients with stage 3,4 esophageal cancer who receive dcf folfox will get probiotics till the end of their chemotherapy period and will be reviewed in comparison to the control group with a standard questionnaire.
Main outcome variables
Age, Sex, Cancer, Probiotic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211024052857N1
Registration date:2021-11-08, 1400/08/17
Registration timing:prospective
Last update:2021-11-08, 1400/08/17
Update count:0
Registration date
2021-11-08, 1400/08/17
Registrant information
Name
Alireza Tojjari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2257 1179
Email address
alirezatojjari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-26, 1400/09/05
Expected recruitment end date
2021-12-26, 1400/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of probiotics administration on acute side effects of chemotherapy regimens in gastroesophageal cancer patients
Public title
The effects of probiotics administration on acute side effects of chemotherapy regimens in gastroesophageal cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with gastroesophageal cancer stage 3,4 who had chemotherapy(dcf,folfox)-induced side effects and were older than 18 with first-grade tumor.
Exclusion criteria:
Patients with severe systematic disease (such as heart, kidney, and liver) or previously had chemotherapy or were given antibiotics and probiotics.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned to receive either probiotic (n = 21) or nothing (control = 21) based on randomized block randomization and stratified randomization. Closed pockets were used to hide the randomization process, which was opened at the time of the patient's visit to minimize the gap between randomization and drug or control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses will be completed. Another person who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered pockets of capsules.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
West Booali st, Nabovat square, Karaj city
City
Karaj
Province
Alborz
Postal code
3149969415
Approval date
2021-02-16, 1399/11/28
Ethics committee reference number
IR.ABZUMS.REC.1399.287
Health conditions studied
1
Description of health condition studied
Gastroesophageal cancers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of side effects of chemotherapy in patients with gastroesophageal cancers
Timepoint
Duration of chemotherapy
Method of measurement
Standard questionnaire based CTCAE
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will be given probiotics (" DailyEast", Zist Takhmir ) once a daily during their chemotherapy.
Category
Prevention
2
Description
Control group: Patients will be given their standard drugs during chemotherapy.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Hospital
Full name of responsible person
Mojan Asadi
Street address
West Booali st, nabovat square, Karaj city
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7369
Email
alirezatojjari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Marzie Tavakol
Street address
West Booali st, Nabovat square, Karaj city
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3428 7339
Email
alirezatojjari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Alireza Tojjari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Hematology
Street address
Unit 12, No 11, Hashemyian St, Neyestan 3rd St, Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946915191
Phone
+98 21 2257 1179
Fax
Email
alirezatojjari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Alireza Tojjari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Hematology
Street address
Unit 12, No 11, Hashemyian St, Neyestan 3rd St, Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946915191
Phone
+98 21 2257 1179
Fax
Email
alirezatojjari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Alireza Tojjari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Hematology
Street address
Unit 12, No 11, Hashemyian St, Neyestan 3rd St, Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946915191
Phone
+98 21 2257 1179
Fax
Email
alirezatojjari@gmail.com
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
Not applicable
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