Acute Radiation Enteritis
Conditions
Keywords
Acute radiation-induced rectal injury, Rectal cancer, Short-course radiotherapy, Bergmann enema
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.
Interventions
DRUGBergmann 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
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Intervention: Patients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 2 or higher radiation-induced rectal injury | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactJie Shi
Outcome results
None listed