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

N/ARecruitingNCT07802002

Sixth Affiliated Hospital, Sun Yat-sen University23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Radiotherapy Radiation-Induced Complications

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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