RecruitingNot ApplicableNCT07802002

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

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

23 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Radiotherapy Radiation-Induced Complications

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). 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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Tributyrin for people with radiation-induced complications and radiotherapy. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTTributyrin

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.