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

NCT07802002 | Recruiting

• 1 other identifier: ARII202601
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiotherapy; Radiation-Induced Complications

Keywords

Radiotherapy; Radiation-induced rectal injury; Tributyrin

Outcome Measures

Primary Outcomes (1)

• 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.

  From the start of radiotherapy to 3 months after completion of radiotherapy

Secondary Outcomes (1)

• Incidence of chronic radiation-induced rectal injury

  From more than 3 months to 12 months after completion of radiotherapy

Study Arms (1)

Dietary supplements

EXPERIMENTAL

Participants receive oral tributyrin in addition to standard neoadjuvant pelvic radiotherapy and standard clinical care.

Dietary Supplement: Tributyrin

Interventions

Tributyrin DIETARY_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.

Dietary supplements

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Interventions

tributyrin

Central Study Contacts

Lekun Fang

CONTACT

+8613560226002; fanglk3@mail.sysu.edu.cn

Weiyao Li

CONTACT

+8618820408830; liwy229@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-08

Locations

CN (1)