Acute Radiation EnteritisPhase 2NCT07548736
Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury
A Phase 2 study testing Experimental Group (dexamethasone enema) in people with Acute Radiation Enteritis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Radiation Enteritis
- What is being tested?
- Experimental Group (dexamethasone enema)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2026to 24 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Xiaosheng He, +862085655905, hexsheng@mail.sysu.edu.cn
About this study
Official title: Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury: a Phase II Randomized Controlled Clinical Trial
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.
Read more
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
- Being tested
- Experimental Group (dexamethasone enema), Control group (dexamethasone enema)
- Keywords
- Acute radiation-induced rectal injury, Rectal cancer, Conventional pelvic radiotherapy, Dexamethasone enema
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Drug: Experimental Group (dexamethasone enema) |
| Control Group | Active comparator | Not described Receives: Drug: Control group (dexamethasone enema) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate of radiation-induced rectal injury
Measured: 3 months
Secondary outcomes (5)
Severity of radiation-induced rectal injury
Assessment criteria: Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) late radiation morbidity scoring system, Vienna Rectoscopy Score
Measured: 3 months
completion rate of pelvic radiotherapy
Measured: 1 year
Incidence and severity of adverse events to dexamethasone enema
assessed according to CTCAE v.5
Measured: 1 year
quality of life
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Measured: 1 year
pathological complete response (pCR) rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start24 Apr 2026 (estimated)
- Primary completion24 Apr 2027 (estimated)
- Study completion24 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Acute Radiation EnteritisStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548736
- Sponsor's protocol ID
- Dex-ARRI
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohammadianpanah M, Tazang M, Nguyen NP, Ahmadloo N, Omidvari S, Mosalaei A, Ansari M, Nasrollahi H, Kadkhodaei B, Khanjani N, Hosseini SV. Preventive efficacy of hydrocortisone enema for radiation proctitis in rectal cancer patients undergoing short-course radiotherapy: a phase II randomized placebo-controlled clinical trial. Ann Coloproctol. 2024 Oct;40(5):506-514. doi: 10.3393/ac.2024.00192.0027. Epub 2024 Oct 22.
PubMed 39434555Sanguineti G, Franzone P, Marcenaro M, Foppiano F, Vitale V. Sucralfate versus mesalazine versus hydrocortisone in the prevention of acute radiation proctitis during conformal radiotherapy for prostate carcinoma. A randomized study. Strahlenther Onkol. 2003 Jul;179(7):464-70. doi: 10.1007/s00066-003-1082-4.
PubMed 12835883Kochhar R, Patel F, Dhar A, Sharma SC, Ayyagari S, Aggarwal R, Goenka MK, Gupta BD, Mehta SK. Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate. Dig Dis Sci. 1991 Jan;36(1):103-7. doi: 10.1007/BF01300096.
PubMed 1670631地塞米松在临床肿瘤治疗中的应用进展
放射性直肠损伤的预防与治疗临床实践指南
中国放射性直肠损伤多学科诊治专家共识（2021版）
中国放射性直肠炎诊治专家共识(2018版)
Paquette IM, Vogel JD, Abbas MA, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of The American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Treatment of Chronic Radiation Proctitis. Dis Colon Rectum. 2018 Oct;61(10):1135-1140. doi: 10.1097/DCR.0000000000001209. No abstract available.
PubMed 30192320Jahraus CD, Bettenhausen D, Malik U, Sellitti M, St Clair WH. Prevention of acute radiation-induced proctosigmoiditis by balsalazide: a randomized, double-blind, placebo controlled trial in prostate cancer patients. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1483-7. doi: 10.1016/j.ijrobp.2005.04.032. Epub 2005 Aug 15.
PubMed 16099600Gami B, Harrington K, Blake P, Dearnaley D, Tait D, Davies J, Norman AR, Andreyev HJ. How patients manage gastrointestinal symptoms after pelvic radiotherapy. Aliment Pharmacol Ther. 2003 Nov 15;18(10):987-94. doi: 10.1046/j.1365-2036.2003.01760.x.
PubMed 14616164Qin Q, Huang B, Cao W, Zhou J, Ma T, Zhou Z, Wang J, Wang L. Bowel Dysfunction After Low Anterior Resection With Neoadjuvant Chemoradiotherapy or Chemotherapy Alone for Rectal Cancer: A Cross-Sectional Study from China. Dis Colon Rectum. 2017 Jul;60(7):697-705. doi: 10.1097/DCR.0000000000000801.
PubMed 28594719Qin Q, Ma T, Deng Y, Zheng J, Zhou Z, Wang H, Wang L, Wang J. Impact of Preoperative Radiotherapy on Anastomotic Leakage and Stenosis After Rectal Cancer Resection: Post Hoc Analysis of a Randomized Controlled Trial. Dis Colon Rectum. 2016 Oct;59(10):934-42. doi: 10.1097/DCR.0000000000000665.
PubMed 27602924Haddock MG, Sloan JA, Bollinger JW, Soori G, Steen PD, Martenson JA; North Central Cancer Treatment Group. Patient assessment of bowel function during and after pelvic radiotherapy: results of a prospective phase III North Central Cancer Treatment Group clinical trial. J Clin Oncol. 2007 Apr 1;25(10):1255-9. doi: 10.1200/JCO.2006.09.0001.
PubMed 17401014Andreyev J. Gastrointestinal symptoms after pelvic radiotherapy: a new understanding to improve management of symptomatic patients. Lancet Oncol. 2007 Nov;8(11):1007-17. doi: 10.1016/S1470-2045(07)70341-8.
PubMed 17976611Kumagai T, Rahman F, Smith AM. The Microbiome and Radiation Induced-Bowel Injury: Evidence for Potential Mechanistic Role in Disease Pathogenesis. Nutrients. 2018 Oct 2;10(10):1405. doi: 10.3390/nu10101405.
PubMed 30279338
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury: a Phase II Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07548736
- Acronym / sponsor ID
- Dex-ARRI
- Conditions
- Acute Radiation Enteritis
- Keywords
- Acute radiation-induced rectal injury, Rectal cancer, Conventional pelvic radiotherapy, Dexamethasone enema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 Apr 2026 (estimated)
- Primary completion
- 24 Apr 2027 (estimated)
- Study completion
- 24 Apr 2028 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Experimental Group (dexamethasone enema) |
| Control Group | Active comparator | Drug: Control group (dexamethasone enema) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Experimental Group |
| 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. | Drug | Control Group |
Primary outcome
Improvement rate of radiation-induced rectal injury
Time frame: 3 months
5 secondary outcomes
Severity of radiation-induced rectal injury
Time frame: 3 months
completion rate of pelvic radiotherapy
Time frame: 1 year
Incidence and severity of adverse events to dexamethasone enema
Time frame: 1 year
quality of life
Time frame: 1 year
pathological complete response (pCR) rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Results publication: PubMed 39434555Mohammadianpanah M, Tazang M, Nguyen NP, Ahmadloo N, Omidvari S, Mosalaei A, Ansari M, Nasrollahi H, Kadkhodaei B, Khanjani N, Hosseini SV. Preventive efficacy of hydrocortisone enema for radiation proctitis in rectal cancer patients undergoing short-course radiotherapy: a phase II randomized placebo-controlled clinical trial. Ann Coloproctol. 2024 Oct;40(5):506-514. doi: 10.3393/ac.2024.00192.0027. Epub 2024 Oct 22.
- Results publication: PubMed 12835883Sanguineti G, Franzone P, Marcenaro M, Foppiano F, Vitale V. Sucralfate versus mesalazine versus hydrocortisone in the prevention of acute radiation proctitis during conformal radiotherapy for prostate carcinoma. A randomized study. Strahlenther Onkol. 2003 Jul;179(7):464-70. doi: 10.1007/s00066-003-1082-4.
- Results publication: PubMed 1670631Kochhar R, Patel F, Dhar A, Sharma SC, Ayyagari S, Aggarwal R, Goenka MK, Gupta BD, Mehta SK. Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate. Dig Dis Sci. 1991 Jan;36(1):103-7. doi: 10.1007/BF01300096.
- Results publication地塞米松在临床肿瘤治疗中的应用进展
- Results publication放射性直肠损伤的预防与治疗临床实践指南
- Results publication中国放射性直肠损伤多学科诊治专家共识（2021版）
- Results publication中国放射性直肠炎诊治专家共识(2018版)
- Results publication: PubMed 30192320Paquette IM, Vogel JD, Abbas MA, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of The American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Treatment of Chronic Radiation Proctitis. Dis Colon Rectum. 2018 Oct;61(10):1135-1140. doi: 10.1097/DCR.0000000000001209. No abstract available.
- Results publication: PubMed 16099600Jahraus CD, Bettenhausen D, Malik U, Sellitti M, St Clair WH. Prevention of acute radiation-induced proctosigmoiditis by balsalazide: a randomized, double-blind, placebo controlled trial in prostate cancer patients. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1483-7. doi: 10.1016/j.ijrobp.2005.04.032. Epub 2005 Aug 15.
- Results publication: PubMed 14616164Gami B, Harrington K, Blake P, Dearnaley D, Tait D, Davies J, Norman AR, Andreyev HJ. How patients manage gastrointestinal symptoms after pelvic radiotherapy. Aliment Pharmacol Ther. 2003 Nov 15;18(10):987-94. doi: 10.1046/j.1365-2036.2003.01760.x.
- Results publication: PubMed 28594719Qin Q, Huang B, Cao W, Zhou J, Ma T, Zhou Z, Wang J, Wang L. Bowel Dysfunction After Low Anterior Resection With Neoadjuvant Chemoradiotherapy or Chemotherapy Alone for Rectal Cancer: A Cross-Sectional Study from China. Dis Colon Rectum. 2017 Jul;60(7):697-705. doi: 10.1097/DCR.0000000000000801.
- Results publication: PubMed 27602924Qin Q, Ma T, Deng Y, Zheng J, Zhou Z, Wang H, Wang L, Wang J. Impact of Preoperative Radiotherapy on Anastomotic Leakage and Stenosis After Rectal Cancer Resection: Post Hoc Analysis of a Randomized Controlled Trial. Dis Colon Rectum. 2016 Oct;59(10):934-42. doi: 10.1097/DCR.0000000000000665.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental Group (dexamethasone enema) in people with Acute Radiation Enteritis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaosheng He (+862085655905, hexsheng@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate of radiation-induced rectal injury (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07548736, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.