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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of grade 2 or higher radiation-induced rectal injury
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Bergmann enema (Drug)
结局指标
主要结局
Incidence of grade 2 or higher radiation-induced rectal injury
时间窗: 3 months
次要结局
- 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)