Comparison of the efficacy of sucralfate ointment versus placebo in prevention of acute proctitis induced by radiotherapy in cancer patients: a randomized controlled clinical trial
This study is a phase 2, double-blinded, randomized, placebo controlled, single center clinical trial conducted at Radiotherapy Center of Imam Khomeini Hospital in Sari. Patients aged over 18 years who receive pelvic radiation will be randomized into two groups including 30 participants in each group using random number table. In this study, the efficacy of sucralfate in prevention of acute radiation proctitis will be evaluated. The intervention group will receive topical sucralfate ointment and the control group will receive placebo ointment twice a day for six weeks. The patients will be followed in terms of occurrence of proctitis for 6 weeks. The primary end points are proctitis development based on clinical presentation, the severity of proctitis based on Radiation therapy oncology group (RTOG) criteria and the secondary outcomes will be the effects of proctitis on lifestyle (by a method described by Kennedy et al., 2001), quantitative CRP and social-psychological state based on Hospital Anxiety-Depression (HAD) scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606042027N7
Registration date:2016-09-22, 1395/07/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-22, 1395/07/01
Registrant information
Name
Ebrahim Salehifar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1311 6546
Email address
esalehifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Mazandaran University of Medical Sciences
Expected recruitment start date
2015-11-21, 1394/08/30
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of sucralfate ointment versus placebo in prevention of acute proctitis induced by radiotherapy in cancer patients: a randomized controlled clinical trial
Public title
The efficacy of sucralfate in prevention of acute proctitis induced by radiotherapy in cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: patients aged older than 18 years; need for pelvic radiation. Exclusion Criteria: Evidence of active infection; evidence of other sources of hematochezia including colon cancer, inflammatory bowel disease, and hemorrhoids; anal incontinence; anorectal fistula; anorectal stenosis; previous rectal surgery; pregnancy or breast feeding; female of child-bearing age who doesn't use a secure contraception method; known allergy to any ingredients of ointments; concurrent use of antibiotics or steroids
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization will be done using random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Faculty of Pharmacy, Payambar Azam Complex, kilometer 18 of Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
City
Sari
Postal code
Approval date
2015-11-10, 1394/08/19
Ethics committee reference number
IR.MAZUMS.REC.94-1743
Health conditions studied
1
Description of health condition studied
acute radiation proctitis
ICD-10 code
62.7
ICD-10 code description
Radiation proctitis
Primary outcomes
1
Description
Developement of proctitis
Timepoint
before intervention, then weekly for six weeks after intervention
Method of measurement
based on clinical presentation
2
Description
proctitis severity
Timepoint
before intervention, then weekly for six weeks after intervention
Method of measurement
based on Radiation Therapy Oncology Group (RTOG) criteria
Secondary outcomes
1
Description
The effect of paroctitis on the lifestyle with a scoring system described by Kennedy et al, 2001
Timepoint
before intervention, then weekly for six weeks after intervention
Method of measurement
based on questionnaire
2
Description
Quantitative CRP
Timepoint
before intervention, then weekly for six weeks after intervention
Method of measurement
based on patient's blood sample
3
Description
Patient's psycho-social state
Timepoint
before intervention, then weekly for six weeks after intervention
Method of measurement
based on Hospital Anxiety-Deprresion (HAD) scale
Intervention groups
1
Description
Intervention group: sucralfate ointment 1 g twice daily from the first day of study for six weeks
Category
Treatment - Drugs
2
Description
Control group: placebo ointment 1 g twice daily from the first day of study for six weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy Center of Sari Imam Khomeini Hospital
Full name of responsible person
Sara Sai
Street address
Radiotherapy Center of the Emam Khomeini Hospital, Amir Mazandarani Blvd, Sari, Mazandaran Province, Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moallem Square, Sari
City
Sari
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences, Faculty of Pharmacy
Full name of responsible person
Ebrahim Salehifar
Position
Faculty Member, Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy, Payambar Azam's Complex of Mazandaran University of Medical Sciences, kilometer 18 of Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Faculty Member, Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy, Payambar Azam's Complex of Mazandaran University of Medical Sciences, kilometer 18 of Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
Faculty of Pharmacy, Payambar Azam's Complex of Mazandaran University of Medical Sciences, kilometer 18 of Farah Abad Blvd, Khazar square, Sari, Mazandaran Province