Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury

Last updated: June 4, 2024
Sponsor: Fujian Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rectal Disorders

Treatment

Triethanolamine cream

Clinical Study ID

NCT06325982
BYFFL-01
  • All Genders

Study Summary

The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • There are clear indications for radiotherapy (pelvic radiotherapy or rectalradiotherapy) according to relevant guidelines;

  • ECOG score 0-1;

  • normal mind, clear consciousness;

  • High compliance;

  • Able to cooperate with the interviewer

Exclusion

Exclusion Criteria:

  • Poor compliance, unwilling to participate or unable to cooperate with theinterviewer;

  • Patients with other intestinal diseases (such as Crohn's disease, rectal ulcer, analfissure, anal fistula, hemorrhoids, etc.) and perianal diseases;

  • serious heart, brain, liver, kidney disease;

  • Long-term immune dysfunction;

  • Pregnant or lactating women;

  • Patients who terminate treatment for various reasons.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Triethanolamine cream
Phase:
Study Start date:
June 11, 2024
Estimated Completion Date:
December 31, 2025

Study Description

The study was a prospective, multicenter, real-world study with eligible patient data as of May 1, 2024. The prospective study was a continuous, multicenter study.

Connect with a study center

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Active - Recruiting

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