Dietary Supplements to Treat Radiation-Induced Rectal Injury

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Jan 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a dietary supplement called tributyrin (TB) to help treat rectal problems caused by radiation therapy, a condition known as radiation-induced rectal injury. The researchers believe that taking these supplements may reduce symptoms like rectal bleeding and improve the overall quality of life for patients who have had pelvic radiation treatment. To see if the supplements work, the study will measure changes in rectal bleeding and overall health through blood tests and other safe methods, all while ensuring that participants feel comfortable throughout the trial.

To be eligible for this study, participants must be between 18 and 75 years old and should have completed their pelvic radiation therapy at least three months prior. They should also have mild to moderate rectal bleeding but cannot have serious complications or other health issues that could interfere with the study. If you decide to participate, you will receive the supplements and be closely monitored for any changes in your symptoms. This research aims to find a safe and effective way to help patients who are suffering from the side effects of radiation therapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-75 years
• • At least 3 months since the completion of pelvic radiotherapy
• • No evidence of tumor recurrence or metastasis
• • Rectal bleeding with grade 1-2 by LENT-SOMA scales
• Exclusion Criteria:
• • Acute or chronic infectious diseases
• • Serious systemic diseases
• • Known allergies to any components of the study medication
• • Colonoscopy indicating rectal ulceration (\>1cm2), fistula, stricture, or necrosis
• • Late complications related to pelvic radiation injury
• • Other hemorrhagic or coagulation disorders
• • Previous rectal resection
• • Bowel obstruction or perforation that require surgery
• • Cognitive or psychological disorder