Investigating the effectiveness of famotidine as a radioprotector in reducing the mucosal and hematological complications of prostate cancer radiotherapy
Determining the effectiveness of famotidine tablets as a radioprotector in reducing the mucosal and hematological complications of prostate cancer radiotherapy
Design
A clinical trial with a control group, randomized, phase 3 on 50 patients, in which SAS statistical software will be used to generate a random sequence.
Settings and conduct
Place of study: Radiotherapy Department of Imam Reza Hospital, Kermanshah.
Study population: 50 patients with prostate cancer.
Type of blinding In this study, blinding was not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 30 to 75 years with prostate cancer.
Exclusion criteria: lack of consent to participate in the study; Patients with kidney disease that cannot be prescribed famotidine
Intervention groups
Intervention group: 25 patients will receive famotidine tablets (40 mg).
Control group: 25 people will also be studied without receiving pills.
Main outcome variables
mucosal damage, lymphocytopenia, granulocytopenia, thrombocytopenia and anemia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231121060132N1
Registration date:2024-01-16, 1402/10/26
Registration timing:registered_while_recruiting
Last update:2024-01-16, 1402/10/26
Update count:0
Registration date
2024-01-16, 1402/10/26
Registrant information
Name
Iman Fallah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3456 9701
Email address
imen691020@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-26, 1402/09/05
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of famotidine as a radioprotector in reducing the mucosal and hematological complications of prostate cancer radiotherapy
Public title
The effect of famotidine on reducing the side effects of prostate cancer radiotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 30 to 75 with prostate cancer candidates for radiotherapy
Do not receive PPI drugs and other H2 antagonist drugs
Exclusion criteria:
Lack of consent to participate in the study
Patients with kidney disease that cannot be prescribed famotidine
Age
From 30 years old to 75 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups, block randomization using blocks of size four in which two people will be in the intervention group and two people in the control group. Possible quadruple blocks will be randomly selected until the final sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Imam Reza Hospital; Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Approval date
2023-11-21, 1402/08/30
Ethics committee reference number
IR.KUMS.MED.REC.1402.220
Health conditions studied
1
Description of health condition studied
Prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
Mucosal lesions
Timepoint
weekly
Method of measurement
Using the Visual Analogue Scale questionnaire
2
Description
Lymphocytopenia
Timepoint
weekly
Method of measurement
Blood cell count test
3
Description
granulocytopenia
Timepoint
weekly
Method of measurement
Blood cell count test
4
Description
thrombocytopenia
Timepoint
weekly
Method of measurement
Blood cell count test
5
Description
anemia
Timepoint
weekly
Method of measurement
Blood cell count test
Secondary outcomes
empty
Intervention groups
1
Description
The control group does not receive any drug
Category
Prevention
2
Description
Intervention group: Famotidine tablets, 40 mg, daily, 4 hours and 3 hours before radiation therapy
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Kermanshah Hospital
Full name of responsible person
Iman Fallah
Street address
Imam Reza Kermanshah Hospital; Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3423 3765
Email
IMEN691020@GMAIL.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Cirous Jalili
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 11 3456 9701
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Iman Fallah
Position
Radiation oncology resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Golha blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 11 3456 9701
Fax
Email
Imen691020@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maliheh Dayani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Imam Reza Kermanshah Hospital; Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
083342233766
Email
www.d.maliheh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Iman Fallah
Position
Radiation oncology resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Golestan 10; Golestan Street; Golha blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 11 3456 9701
Fax
Email
Imen691020@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
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