Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury

Starting soon · Phase 2

Conditions studied: Acute Radiation Enteritis

In brief

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.

Key facts

Study ID

NCT07548736

Run by

Sixth Affiliated Hospital, Sun Yat-sen University

People needed

40

Starts

2026-04-24

Expected to finish

2028-04-24

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 pathologically diagnosed with rectal cancer;
• Undergoing conventional pelvic radiotherapy (total dose of 40-50.4Gy in 25-28 fractions);
• 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.

You may not qualify if…

• 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 dexamethasone;
• Inability to cooperate with the enema;
• Subjects deemed unsuitable for participation in this trial for other reasons by the researcher.

Where it is running

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

Full record on ClinicalTrials.gov

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