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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

RecruitingNAAges 18 Years - 75 YearsAllSixth Affiliated Hospital, Sun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Tributyrin
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Where

1 site
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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