RadiotherapyNCT07802002
A Prospective, Single-Arm Clinical Study of a Dietary Supplement for the Prevention of Acute Radiation-Induced Rectal Injury During Neoadjuvant Chemoradiotherapy for Rectal Cancer
A study testing Tributyrin in people with Radiotherapy and Radiation-Induced Complications, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as a dietary supplement for preventing acute radiation-induced rectal injury (ARII). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiotherapy, Radiation-Induced Complications
- What is being tested?
- Tributyrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed rectal adenocarcinoma.
- 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.
- ECOG performance status of 0 or 1.
- Baseline defecation frequency < 3 times/day, with no significant abdominal pain or tenesmus.
Who cannot join
- Previous history of total mesorectal excision (TME) or other intestinal resection surgeries.
- Diagnosis of severe diarrhea, Crohn's disease, ulcerative colitis, or chronic radiation enteritis.
- Previous history of pelvic radiotherapy.
- Presence of malignant pleural effusion or malignant ascites, or complete/incomplete intestinal obstruction, rendering the patient unable to tolerate dietary supplement therapy.
- Participation in other investigational drug trials within 4 weeks prior to enrollment.
- Receiving non-conventional chemotherapy regimens (non-fluoropyrimidine drugs) or concurrent participation in other trials involving potent mucosa-damaging drugs.
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- Pregnant or breastfeeding women.
- History of alcoholism, drug abuse, or substance abuse within the past 1 year.
- History of severe allergies or known allergy to the ingredients of the dietary supplement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Lekun Fang, 13560226002, fanglk3@mail.sysu.edu.cn
About this study
This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as a dietary supplement for preventing acute radiation-induced rectal injury (ARII). Approximately 23 participants with locally advanced rectal cancer will receive tributyrin in addition to standard neoadjuvant chemoradiotherapy. We hypothesize that tributyrin will reduce the incidence of grade 2 or higher ARII, graded according to the RTOG/EORTC criteria. Treatment-related adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE), and changes in health-related quality of life and bowel function will be assessed using the EORTC QLQ-C30 and IBD-Q questionnaires.
- Conditions
- Radiotherapy, Radiation-Induced Complications
- Being tested
- Tributyrin
- Keywords
- Radiotherapy, Radiation-induced rectal injury, Tributyrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TributyrinDietary supplement
Participants receive oral tributyrin in addition to standard neoadjuvant pelvic radiotherapy and standard clinical care. Tributyrin is administered at a dose of 1,650 mg three times daily after meals. Intervention will begin on the first day of radiotherapy and continue until 28 days after completion of short-course radiotherapy or 14 days after completion of long-course radiotherapy. Standard clinical care includes dietary counseling, symptom management, probiotics, antidiarrheal agents, antiemetics, oral rehydration salts, and topical skin-care products. Additional treatment may be provided at the investigator's discretion if clinically significant adverse events occur.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplements | Experimental | Participants receive oral tributyrin in addition to standard neoadjuvant pelvic radiotherapy and standard clinical care. Receives: Dietary Supplement: Tributyrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of RTOG grade 2 or higher acute radiation-induced rectal injury
The proportion of participants who develop acute radiation-induced rectal injury of Grade 2 or higher, based on the highest RTOG grade recorded from the start of radiotherapy through 3 months after completion of radiotherapy.
Measured: From the start of radiotherapy to 3 months after completion of radiotherapy
Secondary outcomes (1)
Incidence of chronic radiation-induced rectal injury
The proportion of participants who develop chronic radiation-induced rectal injury during the period from more than 3 months through 12 months after completion of radiotherapy.
Measured: From more than 3 months to 12 months after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802002
- Sponsor's protocol ID
- ARII202601
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Clinical Study of a Dietary Supplement for the Prevention of Acute Radiation-Induced Rectal Injury During Neoadjuvant Chemoradiotherapy for Rectal Cancer
- ClinicalTrials.gov ID
- NCT07802002
- Acronym / sponsor ID
- ARII202601
- Conditions
- Radiotherapy, Radiation-Induced Complications
- Keywords
- Radiotherapy, Radiation-induced rectal injury, Tributyrin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as a dietary supplement for preventing acute radiation-induced rectal injury (ARII). Approximately 23 participants with locally advanced rectal cancer will receive tributyrin in addition to standard neoadjuvant chemoradiotherapy. We hypothesize that tributyrin will reduce the incidence of grade 2 or higher ARII, graded according to the RTOG/EORTC criteria. Treatment-related adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE), and changes in health-related quality of life and bowel function will be assessed using the EORTC QLQ-C30 and IBD-Q questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary supplements | Experimental | Dietary Supplement: TributyrinParticipants receive oral tributyrin in addition to standard neoadjuvant pelvic radiotherapy and standard clinical care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed rectal adenocarcinoma.
- 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.
- ECOG performance status of 0 or 1.
- Baseline defecation frequency < 3 times/day, with no significant abdominal pain or tenesmus.
Key exclusion criteria (9 listed)
- Previous history of total mesorectal excision (TME) or other intestinal resection surgeries.
- Diagnosis of severe diarrhea, Crohn's disease, ulcerative colitis, or chronic radiation enteritis.
- Previous history of pelvic radiotherapy.
- Presence of malignant pleural effusion or malignant ascites, or complete/incomplete intestinal obstruction, rendering the patient unable to tolerate dietary supplement therapy.
- Participation in other investigational drug trials within 4 weeks prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TributyrinParticipants receive oral tributyrin in addition to standard neoadjuvant pelvic radiotherapy and standard clinical care. Tributyrin is administered at a dose of 1,650 mg three times daily after meals. Intervention will begin on the first day of radiotherapy and continue until 28 days after completion of short-course radiotherapy or 14 days after completion of long-course radiotherapy. Standard clinical care includes dietary counseling, symptom management, probiotics, antidiarrheal agents, antiemetics, oral rehydration salts, and topical skin-care products. Additional treatment may be provided at the investigator's discretion if clinically significant adverse events occur. | Dietary supplement | Dietary supplements |
Primary outcome
Incidence of RTOG grade 2 or higher acute radiation-induced rectal injury
Time frame: From the start of radiotherapy to 3 months after completion of radiotherapy
The proportion of participants who develop acute radiation-induced rectal injury of Grade 2 or higher, based on the highest RTOG grade recorded from the start of radiotherapy through 3 months after completion of radiotherapy.
1 secondary outcome
Incidence of chronic radiation-induced rectal injury
Time frame: From more than 3 months to 12 months after completion of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tributyrin in people with Radiotherapy and Radiation-Induced Complications, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lekun Fang (+8613560226002, fanglk3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of RTOG grade 2 or higher acute radiation-induced rectal injury (time frame: From the start of radiotherapy to 3 months after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.