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Recruiting NCT06776016

Dietary Supplements to Treat Radiation-Induced Rectal Injury

Phase II Interventional Radiotherapy Radiation Proctitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Butyrate.
Who it may be relevant to
Registry conditions: Radiotherapy, Radiation Proctitis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Single-Arm, Single-Center Study of Dietary Supplements in the Treatment of Radiation-Induced Rectal Injury

Overview

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.

Interventions

  • Dietary supplement Butyrate
    Agent: The dietary supplement contains tributyrin, a pro-drug of butyrate. Method: Participants receive the supplement orally at a dose of 1650 mg, 2-3 times daily, 12 weeks.

Primary outcome measures

  • Number of participants with alleviated rectal bleeding (degraded by 1 or more) [Time frame: At the time of 12 weeks since the start of treatment]
Secondary outcome measures (1)
  • Number of participants with mild rectal bleeding (grade 0-1) [Time frame: At the time of 24 weeks since the start of treatment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT06776016 · CRP202402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗