Dietary Supplements to Treat Radiation-Induced Rectal Injury

NCT06776016 | Recruiting Phase 2

• 1 other identifier: CRP202402
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Radiotherapy; Radiation Proctitis

Keywords

radiotherapy; radiation proctitis; tributyrin; rectal bleeding; butyrate

Outcome Measures

Primary Outcomes (1)

• Number of participants with alleviated rectal bleeding (degraded by 1 or more)

  The symptom of rectal bleeding will be assessed by LENT-SOMA scales

  At the time of 12 weeks since the start of treatment

Secondary Outcomes (1)

• Number of participants with mild rectal bleeding (grade 0-1)

  At the time of 24 weeks since the start of treatment

Study Arms (1)

Dietary supplements

EXPERIMENTAL

Participants receive dietary supplements combined with supportive care.

Dietary Supplement: Butyrate

Interventions

Butyrate DIETARY_SUPPLEMENT

Agent: The dietary supplement contains tributyrin, a pro-drug of butyrate. Method: Participants receive the supplement orally at a dose of 20 ml, 2-3 times daily, 12 weeks.

Dietary supplements

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Butyrates

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Central Study Contacts

Lekun Fang

CONTACT

+86-13560226002; fanglk3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: January 15, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

CN (1)