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

Official 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

Overview

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

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

Primary outcome measures

• Incidence of grade 2 or higher radiation-induced rectal injury [Time frame: 3 months]

Secondary outcome measures (4)

• Severity of radiation-induced rectal injury [Time frame: 3 months]
• Completion rate of short-course radiotherapy [Time frame: 9 months]
• Safety of Bergmann enema [Time frame: 9 months]
• Pathological complete response (pCR) rate [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

China · 1 center

• The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou

Publications

• Kennedy M, Bruninga K, Mutlu EA, Losurdo J, Choudhary S, Keshavarzian A. Successful and sustained treatment of chronic radiation proctitis with antioxidant vitamins E and C. Am J Gastroenterol. 2001 Apr;96(4):1080-4. doi: 10.1111/j.1572-0241.2001.03742.x. PMID 11316150
• Ehrenpreis ED, Jani A, Levitsky J, Ahn J, Hong J. A prospective, randomized, double-blind, placebo-controlled trial of retinol palmitate (vitamin A) for symptomatic chronic radiation proctopathy. Dis Colon Rectum. 2005 Jan;48(1):1-8. doi: 10.1007/s10350-004-0821-7. PMID 15690650
• 王楠, 丁田贵与尹立杰, 医用射线防护喷剂防治放射性口腔黏膜炎的临床观察. 口腔医学, 2020. 40(08): 第728-730+737页.
• 李祎萍, 医用射线防护喷剂应用在乳腺癌患者急性放射性皮肤损伤中的效果. 实用临床护理学电子杂志, 2016. 1(12): 第167+169页.
• 张力元等, 医用射线防护喷剂防治皮肤黏膜放射性损伤的临床观察. 中华放射医学与防护杂志, 2006(06): 第597-599页.
• 张慧, 章真与袁双虎, 放射性直肠损伤的预防与治疗临床实践指南. 中华肿瘤防治杂志, 2023. 30(5): 第245-259页.
• 中华医学会外科学分会结直肠外科学组, 中国医师协会外科医师分会结直肠外科医师委员会与中国抗癌协会大肠癌专业委员会, 中国放射性直肠损伤多学科诊治专家共识（2021版）. 中华胃肠外科杂志, 2021. 24(11): 第937-949页.
• 中国医师协会外科医师分会与中华医学会外科学分会结直肠外科学组, 中国放射性直肠炎诊治专家共识(2018版). 中华胃肠外科杂志, 2018. 21(12): 第1321-1336页.

Identifiers

NCT: NCT07302126 · Berg-ARRI-SCRT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗