Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06776016

Dietary Supplements to Treat Radiation-Induced Rectal Injury

Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-05-13

33

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as dietary supplements in the treatment of chronic radiation-induced rectal injury (RRI). We hypothesize that these supplements will help improve rectal bleeding symptoms and elevate the quality of life for patients. The study will test whether the supplements can lower the LENT-SOMA scales of rectal bleeding and enhance overall patient health. Efficacy will be evaluated through blood tests and other non-invasive methods, ensuring patient safety and comfort throughout the study.

CONDITIONS

Official Title

Dietary Supplements to Treat Radiation-Induced Rectal Injury

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Actively Recruiting

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Research Team

L

Lekun Fang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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