NCT07302126Not yet recruitingPhase 2
Preventive Efficacy of Bergmann Enema for Acute Radiation-induced Rectal Injury in Rectal Cancer Patients Undergoing Short-course Radiotherapy
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
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 11 Dec 2025
- Start date
- Dec 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT07302126
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From Dec 2025 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received pelvic radiotherapy;
- Patients expected to undergo major surgery during the study period;
- Participation in other clinical trials within 4 weeks prior to enrollment;
Other illness
- 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;
- Presence of malignant pleural effusion or malignant abdominal effusion, or accompanied by bowel obstruction;
- A history of alcohol abuse, drug use, or substance abuse within the past year;
- Severe allergic constitution, or allergy to Bergmann;
Other
- Pregnant or breastfeeding women;
- Inability to cooperate with the enema;
- Subjects deemed unsuitable for participation in this trial for other reasons by the researcher.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.