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Can a Butter-Derived supplement protect the gut during cancer radiation?

NCT ID NCT07802002

Prevention 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

Researchers are testing whether tributyrin, a dietary supplement, can prevent radiation-induced rectal injury in people receiving chemoradiotherapy for locally advanced rectal cancer. About 23 participants will take tributyrin three times daily alongside standard treatment. The study measures how many develop moderate-to-severe rectal injury and tracks side effects, quality of life, and bowel function. If tributyrin helps, it could offer a simple way to reduce a common and painful complication of cancer therapy.

What this could mean

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

Active substance
tributyrin, a dietary supplement
What this could lead to
If it works, tributyrin could become a simple, low-cost way to protect the rectum from radiation damage during rectal cancer treatment, reducing painful side effects and improving quality of life.
What could go wrong
This is a small, early-stage study with only 23 participants, so results may not apply broadly. Tributyrin may not reduce injury, and any benefit must be weighed against potential digestive side effects.

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 23 people

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

Started

Jul 2026

Expected to finish

Dec 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 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. Histologically confirmed rectal adenocarcinoma. 2. Clinically staged as locally advanced rectal cancer (cT3-4 and/or N+). Planned to receive short-course radiotherapy or long-course radiotherapy combined with concurrent fluoropyrimidine-based chemotherapy. 3. ECOG performance status of 0 or 1. 4. Baseline defecation frequency \< 3 times/day, with no significant abdominal pain or tenesmus. Exclusion Criteria: 1. Previous history of total mesorectal excision (TME) or other intestinal resection surgeries. 2. Diagnosis of severe diarrhea, Crohn's disease, ulcerative colitis, or chronic radiation enteritis. 3. Previous history of pelvic radiotherapy. 4. Presence of malignant pleural effusion or malignant ascites, or complete/incomplete intestinal obstruction, rendering the patient unable to tolerate dietary supplement therapy. 5. Participation in other investigational drug trials within 4 weeks prior to enrollment. 6. Receiving non-conventional chemotherapy regimens (non-fluoropyrimidine drugs) or concurrent participation in other trials involving potent mucosa-damaging drugs. 7. Pregnant or breastfeeding women. 8. History of alcoholism, drug abuse, or substance abuse within the past 1 year. 9. History of severe allergies or known allergy to the ingredients of the dietary supplement.

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Conditions

The condition(s) this trial relates to.

radiation-induced disorder rectal cancer radiation proctitis prevention target

As listed by the trial registrant

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

Radiation-induced complications Radiotherapy

How to take part

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  1. The places running it

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  2. The official record

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

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  3. A doctor treating you

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Contacts and locations

Locations

  • Sixth Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510655, China

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