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Could a simple steroid enema heal radiation damage in the gut?

NCT ID NCT06410443

Disease control Sponsor: General Hospital of Shenyang Military Region Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a steroid (dexamethasone) given as an enema can help heal intestinal damage caused by radiation therapy in cancer patients. The trial will enroll 60 adults with moderate to severe acute radiation-induced rectosigmoid injury. Participants will receive either the steroid enema plus standard care, or standard care alone, for one week. The goal is to see if the steroid reduces symptoms like abdominal pain, diarrhea, and bleeding, and improves healing seen on endoscopy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexamethasone (a steroid) given as a retention enema
What this could lead to
If it works, this could offer a simple, non-invasive way to treat painful intestinal damage caused by radiation therapy, helping patients recover faster.
What could go wrong
This is a small, early-stage trial with only 60 participants, so results may not apply to everyone. Steroids can have side effects, and previous studies on this approach have had mixed results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

radiation injury radiation-induced disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Radiation-induced intestinal injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Shenyang, Liaoning, 110840, China

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