Acute Radiation Enteritis
Conditions
Keywords
Acute radiation-induced rectal injury, Rectal cancer, Conventional pelvic radiotherapy, Dexamethasone enema
Brief summary
Research Objective and Principle: Through a randomized controlled study, evaluate the effectiveness of dexamethasone in improving radiation-induced rectal injury in rectal cancer patients undergoing pelvic radiotherapy, thereby providing evidence for treatment options in patients at risk of radiation-induced rectal injury and aiming for adoption in international guidelines. Primary Objective: Improvement rate of radiation-induced rectal injury. Secondary Objectives: Severity of radiation-induced rectal injury, completion rate of pelvic radiotherapy, safety of dexamethasone enema, quality of life, pathological complete response (pCR) rate. Study Design: Prospective, single-center, randomized controlled study. Study Population and Expected Enrollment: Patients with rectal cancer undergoing conventional pelvic radiotherapy, expecting to enroll 40 patients. Trial Duration: From February 2026 to February 2028. Intervention: Experimental Group: Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from day 10 of radiotherapy until radiotherapy completion. Control Group: Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from the occurrence of radiation-induced rectal injury until radiotherapy completion. Statistical Hypothesis: Based on previous reports, the incidence of acute radiation-induced rectal injury is 86%, and it is expected that the experimental group can reduce it to 40%. The sample size was estimated using a formula designed to compare 2 proportions, 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
DRUGExperimental Group (dexamethasone enema)
Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from day 10 of radiotherapy until radiotherapy completion.
DRUGControl group (dexamethasone enema)
Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from the occurrence of radiation-induced rectal injury until radiotherapy completion.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 pathologically diagnosed with rectal cancer; 4. Undergoing conventional pelvic radiotherapy (total dose of 40-50.4Gy in 25-28 fractions); 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 dexamethasone; 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 |
|---|---|
| Improvement rate of radiation-induced rectal injury | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of radiation-induced rectal injury | 3 months | Assessment criteria: Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) late radiation morbidity scoring system, Vienna Rectoscopy Score |
| completion rate of pelvic radiotherapy | 1 year | — |
| Incidence and severity of adverse events to dexamethasone enema | 1 year | assessed according to CTCAE v.5 |
| quality of life | 1 year | Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) |
| pathological complete response (pCR) rate | 1 year | — |
Countries
China
Contacts
CONTACTXiaosheng He
Outcome results
None listed