NCT07548736Not yet recruitingPhase 2
Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury
Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury: a Phase II Randomized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 24 Feb 2026
- Start date
- 24 Apr 2026
- Primary completion date
- 24 Apr 2027
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT07548736
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 24 Apr 2026 to the primary completion date, 24 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received pelvic radiotherapy;
- Patients expected to undergo major surgery during the study period;
- Participation in other clinical trials within 4 weeks prior to enrollment;
Other illness
- 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;
- Presence of malignant pleural effusion or malignant abdominal effusion, or accompanied by bowel obstruction;
- A history of alcohol abuse, drug use, or substance abuse within the past year;
- Severe allergic constitution, or allergy to dexamethasone;
Other
- Pregnant or breastfeeding women;
- Inability to cooperate with the enema;
- Subjects deemed unsuitable for participation in this trial for other reasons by the researcher.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.