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
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Incidence of grade 2 or higher radiation-induced rectal injury
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Bergmann enema (Drug)
Outcomes
Primary Outcomes
Incidence of grade 2 or higher radiation-induced rectal injury
Time Frame: 3 months
Secondary Outcomes
- Severity of radiation-induced rectal injury(3 months)
- Completion rate of short-course radiotherapy(9 months)
- Safety of Bergmann enema(9 months)
- Pathological complete response (pCR) rate(1 year)