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

December 11, 2025 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy: a Prospective, Single-arm, Phase II Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 to 75 years, regardless of gender;
  2. Fully understand this study and voluntarily sign the informed consent form, able to comply with the study protocol and complete all trial procedures;
  3. Patients with pathologically confirmed mid-lower rectal cancer;
  4. Undergoing short-course pelvic radiotherapy (total dose of 25-35Gy in 5.0-7.0 fractions over 5 consecutinve days);
  5. Eastern Cooperative Oncology Group (ECOG) score of 0-1, with an expected survival time of more than 6 months;
  6. Assessment by the attending physician and researcher indicates that vital organ function can tolerate the treatment risks.

Exclusion Criteria:

  1. Severe comorbidities, including uncontrolled stable medical diseases after treatment, or a history of neurological or psychiatric disorders (such as dementia or epilepsy), making them unsuitable for radiotherapy;
  2. Patients who have received pelvic radiotherapy;
  3. Presence of malignant pleural effusion or malignant abdominal effusion, or accompanied by bowel obstruction;
  4. Pregnant or breastfeeding women;
  5. Patients expected to undergo major surgery during the study period;
  6. Participation in other clinical trials within 4 weeks prior to enrollment;
  7. A history of alcohol abuse, drug use, or substance abuse within the past year;
  8. Severe allergic constitution, or allergy to Bergmann;
  9. Inability to cooperate with the enema;
  10. Subjects deemed unsuitable for participation in this trial for other reasons by the researcher.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Patients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of grade 2 or higher radiation-induced rectal injury
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Severity of radiation-induced rectal injury
Time Frame: 3 months
3 months
Completion rate of short-course radiotherapy
Time Frame: 9 months
9 months
Safety of Bergmann enema
Time Frame: 9 months
9 months
Pathological complete response (pCR) rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 11, 2025

Primary Completion (Estimated)

September 11, 2026

Study Completion (Estimated)

December 11, 2026

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Berg-ARRI-SCRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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