The efficacy of sucralfate in prevention of acute proctitis induced by radiotherapy in cancer patients

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201606042027N7

Enrollment

Registered

2016-09-22

Start date

2015-11-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute radiation proctitis. Radiation proctitis

Interventions

Intervention 1: Intervention group: sucralfate ointment 1 g twice daily from the first day of study for six weeks. Intervention 2: Control group: placebo ointment 1 g twice daily from the first day of

Treatment - Drugs

Placebo

Intervention group: sucralfate ointment 1 g twice daily from the first day of study for six weeks

Control group: placebo ointment 1 g twice daily from the first day of study for six weeks

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Developement of proctitis. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on clinical presentation.;Proctitis severity. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on Radiation Therapy Oncology Group (RTOG) criteria.	—

Secondary

Measure	Time frame
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.;Quantitative CRP. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on patient's blood sample.;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.	—

Measure

Time frame

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.;Quantitative CRP. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on patient's blood sample.;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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEbrahim Salehifar

Mazandaran University of Medical Sciences, Faculty of Pharmacy

Esalehifar@Mazums.ac.ir; Salehifare@yahoo.com; esalehifar52@gmail.com+98 11 3354 3082

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026