An interventional study of Tributyrin in Radiotherapy and Radiation-Induced Complications, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Not applicable, Interventional, and Prevention
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.
Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 217 studies on the registry; 111 are open to participants now.
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ECOG performance status
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Investigational drug or device
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Participants receive oral tributyrin in addition to standard neoadjuvant pelvic radiotherapy and standard clinical care.
Dietary Supplement: Tributyrin
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.
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.
Time frame: From the start of radiotherapy to 3 months after completion of radiotherapy
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.
Time frame: From more than 3 months to 12 months after completion of radiotherapy
Started Jul 2026 (actual). Primary completion is estimated for Dec 2027, 17 months after the start.
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Studies of the drug tested here: Tributyrin
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