?ydrocortisone enema in prevention of radiation-induced acute proctitis

Comparison of hydrocortisone enema efficacy with placebo to prevent radiation-induced acute proctitis in rectal cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230122057175N1

Enrollment

100

Registered

2023-02-14

Start date

2023-03-21

Completion date

Unknown

Last updated

2023-03-13

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

Conditions

Radiation proctitis. Radiation proctitis

Interventions

Intervention 1: Intervention group: From the beginning of radiotherapy, patients in the intervention group will be treated with hydrocortisone enema (100 mg) daily. The hydrocortisone solution is prov

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age between 18-65 years old ECOG performance score of 0-1 Newly diagnosed rectal cancer patient Definitive histologic diagnosis

Exclusion criteria

Exclusion criteria: Not giving informed consent to much Presence of chronic underlying hepatic, renal, and cardiac disorders Previous history of malignancies Previous history of pelvic radiotherapy Presence of distant metastasis at the presentation Synchronous malignant lesions of bowel at the presentation Presence of bowel obstruction symptoms

Design outcomes

Primary

Measure	Time frame
Severity of proctitis. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.;Severity of diarrhea. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.;Severity of rectal bleeding. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.;Severity of anal pain. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.;Severity of tenesmus. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.	—

Measure

Time frame

Severity of proctitis. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.;Severity of diarrhea. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.;Severity of rectal bleeding. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.;Severity of anal pain. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.;Severity of tenesmus. Timepoint: The beginning of the study and the weekly during radiotherapy. Method of measurement: Based on Common Terminology Criteria for Adverse Events.

—

Secondary

Measure	Time frame
???? ?? ??? ?????. Timepoint: Weekly during the radiotherapy. Method of measurement: Patient visit.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Tazang

Shiraz University of Medical Sciences

Maryamtazang31@gmail.com+98 71 3626 0406

Outcome results

None listed

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