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NCT Number: NCT07302126

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

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.

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Key information

Conditions

Acute Radiation Enteritis Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location contact

Lin Xiao Pang

CONTACT

[email protected]

+862085655905

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • Patients who have received pelvic radiotherapy;
  • Presence of malignant pleural effusion or malignant abdominal effusion, or accompanied by bowel obstruction;
  • Pregnant or breastfeeding women;
  • Patients expected to undergo major surgery during the study period;
  • Participation in other clinical trials within 4 weeks prior to enrollment;
  • A history of alcohol abuse, drug use, or substance abuse within the past year;
  • Severe allergic constitution, or allergy to Bergmann;
  • Inability to cooperate with the enema;
  • Subjects deemed unsuitable for participation in this trial for other reasons by the researcher.

Treatment and study plan

Bergmann enema

Drug

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

Primary outcomes

  1. Incidence of grade 2 or higher radiation-induced rectal injury

    Time frame: 3 months

Secondary outcomes

  1. Severity of radiation-induced rectal injury

    Time frame: 3 months

  2. Completion rate of short-course radiotherapy

    Time frame: 9 months

  3. Safety of Bergmann enema

    Time frame: 9 months

  4. Pathological complete response (pCR) rate

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Shi

CONTACT

[email protected]

+862085655905

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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