Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury

December 17, 2025 updated by: Xingshun Qi, General Hospital of Shenyang Military Region

Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury: A Randomized Controlled Trial

Due to the increasing number and prolonged survival of malignant tumor patients treated with radiotherapy, the complication, such as acute radiation-induced intestinal injury, has become increasingly significant. Glucocorticoids may play a therapeutic role by regulating the inflammatory response in patients with acute radiation-induced intestinal injury. However, the conclusions of related studies were controversial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of 60 patients with acute radiation-induced intestinal injury will be enrolled. They will be randomly assigned at a 1:1 ratio into glucocorticoid group and standard treatment group. The primary endpoint is the recovery and improvement of acute radiation-induced intestinal injury. The secondary study endpoints include the recurrence and aggravation of radiation-induced intestinal injury, and adverse events.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110840
        • Recruiting
        • Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Grade II-III acute radiation-induced rectosigmoid injury
  2. Signed informed consents
  3. Age ≥18 years
  4. Rstimated survival time >1 year

Exclusion Criteria:

  1. Absolute contraindications to glucocorticoids
  2. A history of glucocorticoids treatment within 3 months
  3. Inflammatory bowel disease or infectious intestinal disease
  4. Recurrence of malignant tumor
  5. Colorectal cancer or metastasis
  6. Severe heart or lung diseases
  7. Recent history of surgery or trauma
  8. Poorly controlled hyperglycemia and hypertension
  9. Active tuberculosis
  10. Ssevere gastrointestinal ulcers
  11. Glaucoma
  12. Sychiatric diseases
  13. Pregnant or lactating

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Glucocorticoids+routine treatment group
Dexamethasone retention enema
Drug: Dexamethasone
Retention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week.
Other Names:
  • RHP
Drug: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
Treatment according to guideline of radiation-induced intestinal injury.
Active Comparator: Routine treatment group
Routine treatment of acute radiation-induced intestinal injury according to the current practice guideline
Drug: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
Treatment according to guideline of radiation-induced intestinal injury.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recovery and/or improvement
Time Frame: 3 months
  1. If patients' clinical symptoms, including abdominal pain, diarrhea, and hematochezia, and intestinal mucosal lesions under endoscopy disappear, the recovery will be defined.
  2. If patients' clinical symptoms alleviate, and/or the Vienna scores evaluated by endoscopy decrease at least 1 point, the improvement will be defined.

The total number and frequency of patients who have both recovery and improvement of radiation-induced intestinal injury after treatment is calculated as the treatment efficacy.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recurrence and/or aggravation
Time Frame: 1 year
Clinical symptoms related to radiation-induced intestinal injury and intestinal mucosal lesions under endoscopy recur or aggravate.
1 year
Adverse events
Time Frame: 1 year
Any adverse event develop.
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
General Hospital of Shenyang Military Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xingshun Qi, The General Hospital of Northern Theater Command
  • Principal Investigator: Xiaofeng Liu, The 960th Hospital of the Chinese People's Liberation Army
  • Principal Investigator: Xiaohua Bao, The 964th Hospital of the Chinese People's Liberation Army
  • Principal Investigator: Cheng Bai, The 967th Hospital of the Chinese People's Liberation Army
  • Principal Investigator: Junchen Ge, The 962rd Hospital of the Chinese People's Liberation Army
  • Principal Investigator: Dongshuai Su, The 963rd Hospital of the Chinese People's Liberation Army
  • Principal Investigator: Wenda Xu, The 81th Group Military Hospital of of the Chinese People's Liberation Army
  • Principal Investigator: Ran Jiang, The 966th Hospital of the Chinese People's Liberation Army
  • Principal Investigator: Yumei Hou, 92493 Hospital of the Chinese People's Liberation Army
  • Principal Investigator: Hong Dai, Liaoning Provincial Corps Hospital of the Chinese People's Armed Police
  • Principal Investigator: Bingguo Piao, The 78th Group Military Hospital of the Chinese People's Liberation Army
  • Principal Investigator: Yufeng Zhang, The 79th Group Military Hospital of of the Chinese People's Liberation Army
  • Principal Investigator: Lichun Shao, Air Force Hospital of Northern Theater Command
  • Principal Investigator: Haijun Liang, 96605 Hospital of the Chinese People's Liberation Army

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XHNKKY-RII-RCT

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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