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

NCT07548736 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Dex-ARRI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Radiation Enteritis

Keywords

Acute radiation-induced rectal injury; Rectal cancer; Conventional pelvic radiotherapy; Dexamethasone enema

Outcome Measures

Primary Outcomes (1)

• Improvement rate of radiation-induced rectal injury

  3 months

Secondary Outcomes (5)

• Severity of radiation-induced rectal injury

  3 months

• completion rate of pelvic radiotherapy

  1 year

• Incidence and severity of adverse events to dexamethasone enema

  1 year

• quality of life

  1 year

• pathological complete response (pCR) rate

  1 year

Study Arms (2)

Experimental Group

EXPERIMENTAL

Drug: Experimental Group (dexamethasone enema)

Control Group

ACTIVE COMPARATOR

Drug: Control group (dexamethasone enema)

Interventions

Experimental Group (dexamethasone enema) DRUG

Patients will receive enema (dexamethasone 1 mL + normal saline to total 30 mL) once daily from day 10 of radiotherapy until radiotherapy completion.

Experimental Group

Control group (dexamethasone enema) DRUG

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

Related Publications (19)

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  PMID: 1670631 RESULT

• 地塞米松在临床肿瘤治疗中的应用进展

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• 放射性直肠损伤的预防与治疗临床实践指南

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• 中国放射性直肠损伤多学科诊治专家共识（2021版）

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• 中国放射性直肠炎诊治专家共识(2018版)

  RESULT

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  PMID: 28594719 RESULT

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  PMID: 33538338 RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Xiaosheng He

CONTACT

+862085655905; hexsheng@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: April 23, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): April 24, 2027
• Study Completion (Estimated): April 24, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)