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Trial registered on ANZCTR


Registration number
ACTRN12612000101886
Ethics application status
Approved
Date submitted
17/12/2011
Date registered
20/01/2012
Date last updated
6/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Radioprotective Effect of Famotidine Against Radiotherapy- induced Acute Toxicity in Patients with Prostate Cancer
Scientific title
A Randomized controled trial of Famotidine as a Radioprotector agent versus Placebo before External Beam Radiotherapy in Patients with Prostate Cancer to Reduce Radiation- induced Acute Bowel & Urinary Toxicity using RTOG Criteria
Secondary ID [1] 279627 0
Nil
Universal Trial Number (UTN)
U1111-1126-4224
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 285422 0
Bowel toxicity 285423 0
Urinary toxicity 285424 0
Condition category
Condition code
Cancer 285604 285604 0 0
Prostate
Oral and Gastrointestinal 285605 285605 0 0
Normal oral and gastrointestinal development and function
Renal and Urogenital 285606 285606 0 0
Normal development and function of male and female renal and urogenital system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral Famotidine 40mg is administrated daily for 2 months twice per day before 2 months Radiotherapy: Once 4 hours before and the other 3 hours before daily Radiotherapy. A Physician determines Bowel & Urinary Toxicities Grade for the patients every week during the treatment by interviewing and blood cell counts are collected biweekly.
Intervention code [1] 283908 0
Prevention
Comparator / control treatment
Placebo tablets exactly are as same as famotidine tablets in all properties just with no active ingredient. The administration of placebo and assessment of Radiotherapy-Induced Toxicity Grade for control Group are as similar as Famotidine Group.
Control group
Placebo

Outcomes
Primary outcome [1] 286170 0
Gastrointestinal Acute Toxicity as assessed using the RTOG Grading Criteria
Timepoint [1] 286170 0
every week during the treatment and one month after end of the treatment
Primary outcome [2] 286171 0
Genitourinary Acute Toxicity as assessed using the RTOG Grading Criteria
Timepoint [2] 286171 0
every week during the treatment and one month after end of the treatment
Secondary outcome [1] 295298 0
Heme Acute Toxicity as assessed using the RTOG Grading Criteria
Timepoint [1] 295298 0
every two weeks during the treatment and one month after end of the treatment

Eligibility
Key inclusion criteria
Patients with Prostate Cancer Candidate for External Beam Radiotherapy
Minimum age
No limit
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with Metastatic Prostate Cancer, Patients with Kidney & Liver dysfunction, Patients who receive any H2– Histamine receptor antagonist simultaneously, Patients with Allergic reaction in consequence of Famotidine Administration.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An off-site person was employed for allocating Famotidine or placebo to Group A or B. Thus every participant who is enrolled in the study receives Famotidine or placebo according to this concealed and randomized schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The PASS11 Computer Software was used to generate a randomization list. 36 Participants are allocated in 2 Groups: Group A & Group B
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4026 0
Iran, Islamic Republic Of
State/province [1] 4026 0
Tehran

Funding & Sponsors
Funding source category [1] 284403 0
University
Name [1] 284403 0
School of Paramedical Sciences, Shahid Beheshti Medical University,
Address [1] 284403 0
Darband Street, Tajrish Square, Tehran, I.R Iran.
Country [1] 284403 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
School of Paramedical Sciences, Shahid Beheshti Medical University,
Address
Darband Street, Tajrish Square, Tehran, I.R Iran.
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 283333 0
Individual
Name [1] 283333 0
Abolfazl Razzaghdoust
Address [1] 283333 0
School of Paramedical Sciences, Shahid Beheshti Medical University, Tehran, I.R Iran.
Country [1] 283333 0
Iran, Islamic Republic Of
Other collaborator category [1] 260403 0
Individual
Name [1] 260403 0
Dr. Hossein Mozdarani
Address [1] 260403 0
School of Medical Sciences, Tarbiat
Modarres University, P.O.Box: 14115-111, Tehran, I.R Iran.
Country [1] 260403 0
Iran, Islamic Republic Of
Other collaborator category [2] 260405 0
Individual
Name [2] 260405 0
Dr.Bahram Mofid
Address [2] 260405 0
Shohadaye Tajrish Hospital, Tajrish Sq, Tehran, I.R Iran.
Country [2] 260405 0
Iran, Islamic Republic Of
Other collaborator category [3] 260406 0
Individual
Name [3] 260406 0
Dr.Seyed Mahmoudreza Aghamiri
Address [3] 260406 0
Shahid Beheshti University
Velenjak avenue, Parvaneh street, Tehran, Iran
Country [3] 260406 0
Iran, Islamic Republic Of
Other collaborator category [4] 260529 0
Individual
Name [4] 260529 0
Amirhossein Heidari
Address [4] 260529 0
Babol paramedical University, ganjafruz street, Babol,Iran
Country [4] 260529 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286361 0
Shahid Beheshti Medical University
Ethics committee address [1] 286361 0
Velenjak avenue, Parvaneh street, Tehran, Iran
Ethics committee country [1] 286361 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 286361 0
20/11/2011
Approval date [1] 286361 0
10/01/2012
Ethics approval number [1] 286361 0
109

Summary
Brief summary
There is some animal and human cell evidences to support a Radioprotectory role for Famotidin. In the last few years there has been increasing interest to find a suitable Radioprotector agent for Radotherapy. The aims of this trial are to
1) determine the efficacy of Famotidine to prevent of bowel Radiation-Induced Toxicity
2) determine the efficacy of Famotidine to prevent of Urinary Radiation-Induced Toxicity
3) determine the efficacy of Famotidine to prevent of Immune system Radiation-Induced Toxicity
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33550 0
Mr Abolfazl Razzaghdoust
Address 33550 0
School of Paramedical Sciences, Shahid Beheshti Medical University, Tehran, I.R Iran. postal code:1971653313
Country 33550 0
Iran, Islamic Republic Of
Phone 33550 0
+98 919 2011639
Fax 33550 0
+98 21 88825904
Email 33550 0
Razzaghdoust@sbmu.ac.ir
Contact person for public queries
Name 16797 0
Mr Abolfazl Razzaghdoust
Address 16797 0
School of Paramedical Sciences, Shahid Beheshti Medical University, Tehran, I.R Iran.
Country 16797 0
Iran, Islamic Republic Of
Phone 16797 0
+98 919 2011639 ( for Tehran, I.R Iran)
Fax 16797 0
+98 21 88825904 ( for Tehran, I.R Iran)
Email 16797 0
Razzaghdoust@sbmu.ac.ir
Contact person for scientific queries
Name 7725 0
Prof Hossein Mozdarani
Address 7725 0
School of Medical Sciences, Tarbiat Modarres University, P.O.Box: 14115-111, Tehran, I.R Iran.
Country 7725 0
Iran, Islamic Republic Of
Phone 7725 0
+98 21 82883830 ( for Tehran, I.R Iran)
Fax 7725 0
+98 21 82884555 ( for Tehran, I.R Iran)
Email 7725 0
mozdarah@modares.ac.ir

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary