Phase 2 Dexamethasone Enema for Radiation-Induced Rectal Injury in Rectal Cancer
ClinicalTrials.gov Studies
Summary
A Phase 2 randomized controlled trial (NCT07548736) has been registered on ClinicalTrials.gov evaluating dexamethasone enema for acute radiation-induced rectal injury in 40 rectal cancer patients undergoing pelvic radiotherapy, running from February 2026 to February 2028. The trial hypothesizes that early dexamethasone intervention (starting day 10 of radiotherapy) can reduce injury incidence from an expected 86% to 40%. This registration serves as a public record of an ongoing clinical investigation; it does not create compliance obligations but provides visibility into active research in this therapeutic area.
“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.”
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What changed
The National Institutes of Health has registered a new Phase 2 clinical trial on ClinicalTrials.gov (NCT07548736) investigating dexamethasone enema for acute radiation-induced rectal injury in rectal cancer patients undergoing pelvic radiotherapy. The prospective, single-center, randomized controlled study plans to enroll 40 patients, with the experimental group receiving early intervention (from day 10 of radiotherapy) and the control group receiving delayed intervention (from occurrence of injury). The study runs from February 2026 through February 2028.
Healthcare providers and clinical investigators conducting similar radiotherapy or supportive care research may find this trial relevant for identifying comparable ongoing research activities. This is an informational registration entry without regulatory or compliance implications; it documents a research activity rather than establishing new standards of care or clinical practice guidelines.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury
Phase 2 NCT07548736 Kind: PHASE2 Apr 23, 2026
Abstract
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 s...
Conditions: Acute Radiation Enteritis
Interventions: Experimental Group (dexamethasone enema), Control group (dexamethasone enema)
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