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

Fujian Provincial Cancer Hospital

Status: Enrolling

Conditions: Radiation Injuries; Rectal Diseases

Treatments: Drug: Triethanolamine cream

Study type: Interventional

Funder types: Other

Identifiers

NCT06325982

BYFFL-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• There are clear indications for radiotherapy (pelvic radiotherapy or rectal radiotherapy) according to relevant guidelines;
• ECOG score 0-1;
• normal mind, clear consciousness;
• High compliance;
• Able to cooperate with the interviewer

Exclusion criteria

• Poor compliance, unwilling to participate or unable to cooperate with the interviewer;
• Patients with other intestinal diseases (such as Crohn's disease, rectal ulcer, anal fissure, 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Triethanolamine cream group

Experimental group

Description:

Triethanolamine cream retention enema was given once every night before going to bed during radiotherapy until the end of radiotherapy. Triethanolamine cream retention enema was given once before going to bed the day after radiotherapy for 3 months

Treatment:

Drug: Triethanolamine cream