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New dressing combo aims to soothe anal pain during rectal cancer radiation

NCT ID NCT06837831

Symptom relief Sponsor: Qianfoshan Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special dressing (Mepilex Lite) placed inside the anal canal, combined with a pain-relieving suppository (indomethacin), can better treat acute radiation dermatitis—painful, red, or ulcerated skin—caused by radiotherapy for rectal cancer. About 274 adults who develop at least grade 2 radiation burns will be split into two groups: one gets routine care plus the suppository, the other gets the same plus the dressing. Researchers will check skin healing and pain levels at 7, 14, and 21 days.

What this could mean

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

Active substance
Mepilex Lite dressing and indomethacin suppository
What this could lead to
If it works, this could offer a more effective way to manage painful radiation burns in the anal area, improving comfort and quality of life during rectal cancer treatment.
What could go wrong
This is a single-center trial with a moderate number of participants. The dressing insertion itself can be painful, and results may not apply to all patients or settings.

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 274 people

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

Started

Feb 2026

Expected to finish

Jul 2027

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. Confirmed rectal cancer by histopathological diagnosis; 2. Individuals with clear indications for radiotherapy; 3. Individuals who receive radiation therapy for the first time and develop grade 2 or higher acute radiation dermatitis after receiving radiation therapy; 4. Age ≥ 18 years old; 5. Those who voluntarily participate in this study and sign the informed consent form. Exclusion criteria 1. Individuals with allergic constitution and allergies to the drugs and materials used in this study; 2. Those who withdraw or interrupt radiotherapy midway; 3. Individuals with mental illness, emotional instability, or inability to express their own feelings; 4. Individuals with various comorbidities such as serious cardiovascular and cerebrovascular diseases, digestive system diseases, hematological diseases, and infectious diseases; 5. Physical condition score (Eastern Cooperative Oncology Group, ECOG) \>3 points; 6. Individuals suffering from anal fissures and other diseases that cause skin damage to the anal canal; 7. Individuals with an artificial anus.

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Conditions

The condition(s) this trial relates to.

anal canal cancer radiodermatitis rectal cancer rectal neoplasm

As listed by the trial registrant

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

Acute radiation dermatitis Anal canal Anal pain Rectal cancer, radiotherapy

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 First Affiliated Hospital of Shandong First Medical University

    RECRUITING

    Jinan, Shandong, 250000, China

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