Tributyrin as a dietary supplement to help prevent radiation-induced rectal injury during rectal cancer chemoradiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm study conducted at a single center to evaluate the safety and potential benefit of tributyrin as a dietary supplement during neoadjuvant chemoradiotherapy for locally advanced rectal cancer. Approximately 23 participants will receive tributyrin in addition to the standard treatment, with outcomes focused on the incidence of grade 2 or higher acute radiation-induced rectal injury. Adverse events will be recorded per CTCAE, and quality of life and bowel function will be measured using the EORTC QLQ-C30 and IBD-Q instruments. The trial aims to see if tributyrin can reduce rectal toxicity without compromising cancer treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sixth Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Lekun Fang
• Email: fanglk3@mail.sysu.edu.cn
• Phone: +8613560226002

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.