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Simple enema may shield rectal cancer patients from radiation side effects

NCT ID NCT07302126

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily Bergmann enema can prevent severe rectal injury caused by radiation therapy in 40 rectal cancer patients. Participants will receive the enema from the start of radiotherapy until 10 days after. The goal is to reduce the rate of moderate-to-severe rectal injury from 80% to 50%.

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

Dec 2025

An estimate. Start dates often move.

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 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 with pathologically confirmed mid-lower rectal cancer; 4. Undergoing short-course pelvic radiotherapy (total dose of 25-35Gy in 5.0-7.0 fractions over 5 consecutinve days); 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 Bergmann; 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

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Contacts and locations

Locations

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655, China

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