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Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy

NCT07302126 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-24

No results posted yet for this study

Summary

Research Objective and Principle: To evaluate the effectiveness of Bergmann enema in preventing acute radiation-induced rectal injury in patients with rectal cancer, thereby providing a basis for treatment options for potential radiation-induced rectal injury patients, aiming for adoption by international guidelines.

Primary Objective: Incidence of grade 2 or higher radiation-induced rectal injury.

Secondary Objectives: Severity of radiation-induced rectal injury, completion rate of short-course radiotherapy, safety of Bergmann enema, quality of life, pathological complete response (pCR) rate.

Study Design: Prospective, single-center, single-arm study.

Study Population and Expected Enrollment: Patients with rectal cancer undergoing short-course radiotherapy, expecting to enroll 40 patients.

Trial Duration: From December 2025 to December 2026.

Intervention: Patients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.

Statistical Hypothesis: Based on previous reports, the incidence of acute radiation-induced rectal injury is 80%, and it is expected that Bergmann enema preventive treatment can reduce it to 50%. The sample size was estimated using a formula designed to calculate single-group rate, with a set at 0.05 and a power of 80%. The study aimed to enroll at least 36 patients. Considering a dropout rate of 10%, at least 40 patients need to be included.

Conditions

  • Acute Radiation Enteritis

Interventions

DRUG

Bergmann enema

Patients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-11
Primary Completion
2026-09-11
Completion
2026-12-11

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07302126 on ClinicalTrials.gov