Dietary Supplements to Treat Radiation-Induced Rectal Injury

Sun Yat-sen University

Status and phase

Enrolling

Phase 2

Conditions

Radiation Proctitis

Radiotherapy

Treatments

Dietary Supplement: Butyrate

Study type

Interventional

Funder types

Other

Identifiers

NCT06776016

CRP202402

Details and patient eligibility

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.

Enrollment

33 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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