Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury

April 21, 2026 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury: a Phase II Randomized Controlled Clinical Trial

Research Objective and Principle: Through a randomized controlled study, evaluate the effectiveness of dexamethasone in improving radiation-induced rectal injury in rectal cancer patients undergoing pelvic radiotherapy, thereby providing evidence for treatment options in patients at risk of radiation-induced rectal injury and aiming for adoption in international guidelines.

Primary Objective: Improvement rate of radiation-induced rectal injury. Secondary Objectives: Severity of radiation-induced rectal injury, completion rate of pelvic radiotherapy, safety of dexamethasone enema, quality of life, pathological complete response (pCR) rate.

Study Design: Prospective, single-center, randomized controlled study. Study Population and Expected Enrollment: Patients with rectal cancer undergoing conventional pelvic radiotherapy, expecting to enroll 40 patients.

Trial Duration: From February 2026 to February 2028.

Intervention:

Experimental Group: Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from day 10 of radiotherapy until radiotherapy completion.

Control Group: Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from the occurrence of radiation-induced rectal injury until radiotherapy completion.

Statistical Hypothesis: Based on previous reports, the incidence of acute radiation-induced rectal injury is 86%, and it is expected that the experimental group can reduce it to 40%. The sample size was estimated using a formula designed to compare 2 proportions, with a set at 0.05 and a power of 80%. The study aimed to enroll at least 36 patients. Considering a dropout rate of 10%, at least 40 patients need to be included.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 to 75 years, regardless of gender;
  2. Fully understand this study and voluntarily sign the informed consent form, able to comply with the study protocol and complete all trial procedures;
  3. Patients pathologically diagnosed with rectal cancer;
  4. Undergoing conventional pelvic radiotherapy (total dose of 40-50.4Gy in 25-28 fractions);
  5. Eastern Cooperative Oncology Group (ECOG) score of 0-1, with an expected survival time of more than 6 months;
  6. Assessment by the attending physician and researcher indicates that vital organ function can tolerate the treatment risks.

Exclusion Criteria:

  1. Severe comorbidities, including uncontrolled stable medical diseases after treatment, or a history of neurological or psychiatric disorders (such as dementia or epilepsy), making them unsuitable for radiotherapy;
  2. Patients who have received pelvic radiotherapy;
  3. Presence of malignant pleural effusion or malignant abdominal effusion, or accompanied by bowel obstruction;
  4. Pregnant or breastfeeding women;
  5. Patients expected to undergo major surgery during the study period;
  6. Participation in other clinical trials within 4 weeks prior to enrollment;
  7. A history of alcohol abuse, drug use, or substance abuse within the past year;
  8. Severe allergic constitution, or allergy to dexamethasone;
  9. Inability to cooperate with the enema;
  10. Subjects deemed unsuitable for participation in this trial for other reasons by the researcher.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Drug: Experimental Group (dexamethasone enema)
Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from day 10 of radiotherapy until radiotherapy completion.
Active Comparator: Control Group
Drug: Control group (dexamethasone enema)
Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from the occurrence of radiation-induced rectal injury until radiotherapy completion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement rate of radiation-induced rectal injury
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of radiation-induced rectal injury
Time Frame: 3 months
Assessment criteria: Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) late radiation morbidity scoring system, Vienna Rectoscopy Score
3 months
completion rate of pelvic radiotherapy
Time Frame: 1 year
1 year
Incidence and severity of adverse events to dexamethasone enema
Time Frame: 1 year
assessed according to CTCAE v.5
1 year
quality of life
Time Frame: 1 year
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
1 year
pathological complete response (pCR) rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 24, 2026

Primary Completion (Estimated)

April 24, 2027

Study Completion (Estimated)

April 24, 2028

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dex-ARRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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