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

NCT07548736 · tracked via the Priya Life Science China tracker

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Phase

Phase 2

Started

2026-04-24

Last updated

2026-04-23

Condition(s) studied

Acute Radiation Enteritis

Investigational drug(s) / intervention(s)

Experimental Group (dexamethasone enema)Control group (dexamethasone enema)

Experimental 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.

Control 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

Improvement rate of radiation-induced rectal injury — 3 months

Trial sites (1)

Facility	City	Region	Status
The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07548736 on ClinicalTrials.gov ↗ ← All trials in China