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Can a simple enema prevent radiation damage during rectal cancer treatment?

NCT ID NCT07548736

Disease control Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a daily dexamethasone enema can prevent or reduce acute rectal injury in 40 rectal cancer patients undergoing pelvic radiotherapy. One group starts the enema early (day 10 of radiation), while the other starts only after injury occurs. The goal is to see if early use lowers injury rates and helps patients complete their full radiation course.

What this could mean

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

Active substance
dexamethasone enema
What this could lead to
If successful, this could provide a simple, low-cost way to prevent or reduce rectal injury during pelvic radiotherapy, helping patients complete their cancer treatment with fewer side effects.
What could go wrong
This is a small, early-phase trial with only 40 participants, so results may not apply to all patients. The treatment is given as an enema, which may be uncomfortable, and dexamethasone can have side effects like irritation or infection.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

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 to 75 years

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. 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.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm radiation proctitis prevention target

As listed by the trial registrant

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

Acute radiation enteritis

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

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655, China

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