A Randomized Controlled Trial of Five - Flavor Sophora Flavescens Enteric - Coated Capsules for Radiation - Induced Proctitis After Pelvic Radiotherapy

NCT07053761 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-206
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this single - center, prospective, randomized controlled study is to assess the therapeutic effects of five - flavor sophora flavescens enteric - coated capsules on radiation - induced proctitis in patients who have undergone pelvic radiotherapy. The main question it aims to answer is: Does five - flavor sophora flavescens enteric - coated capsules treatment improve radiation - induced proctitis in these patients? Participants with radiation - induced proctitis following pelvic radiotherapy will be randomly allocated to either the trial group (receiving the capsules) or the control group (receiving conventional therapy). Assessments will be conducted to compare outcomes between the two groups.

Conditions

Radiation - Induced Proctitis

Keywords

radiation - induced proctitis

Outcome Measures

Primary Outcomes (1)

• Clinical remission rate of acute radiation rectal injury

  Clinical remission rate of acute radiation rectal injury

  3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: five - flavor sophora flavescens enteric - coated capsules plus glutamine and warm - water sitz baths

control group

ACTIVE COMPARATOR

Drug: glutamine and warm - water sitz baths

Interventions

five - flavor sophora flavescens enteric - coated capsules plus glutamine and warm - water sitz baths DRUG

Experimental group: If patients have rectal reactions, RTOG radiation - therapy toxicity grades \>2, plus FOB (+) or fecal calprotectin Fc\>150μg/g, they'll take five - flavor sophora flavescens enteric - coated capsules (4 capsules thrice daily for 8 weeks), plus glutamine and warm - water sitz baths.

Experimental group

glutamine and warm - water sitz baths DRUG

If patients have rectal reactions, RTOG radiation - therapy toxicity grades \>2, plus FOB (+) or fecal calprotectin Fc\>150μg/g, they'll use only glutamine and warm - water sitz baths.

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 - 80 years. Undergoing pelvic radiotherapy with RTOG radiation - toxicity grade ≥2 and FOB (+) or fecal calprotectin Fc\>150μg/g.
• Absolute neutrophil count \>1,500/μL, platelets \>100,000/μL; AST \<45U/L, ALT \<40U/L; creatinine clearance \>50ml/min.
• Willing to sign consent and participate in required tests and follow - up.

You may not qualify if:

• Previous pelvic/abdominal radiotherapy. Other severe intestinal diseases (e.g., Crohn's, ulcerative colitis, colorectal cancer).
• Contraindications to five - flavor sophora flavescens enteric - coated capsules (e.g., prolonged QTc, hypokalemia, use of QTc - prolonging drugs, heart disease).
• Allergy to the capsules or their components. Other therapies for radiation - induced proctitis (e.g., mesalamine, steroids, hyperbaric oxygen, laser therapy) in the past month.
• Uncontrolled diseases that may affect the study, such as organ dysfunction, poorly controlled hypertension, coronary heart disease, arrhythmias, cerebrovascular disease, diabetes; myocardial infarction or heart failure in the past 6 months; jaundice due to hepatic insufficiency; AIDS; uncontrolled coagulation disorders.
• Psychiatric patients unable to complete the study.

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Interventions

Glutamine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06