Radiation-Induced Intestinal InjuryNCT06410443
Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury
A study testing Dexamethasone and Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation in people with Radiation-Induced Intestinal Injury, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Due to the increasing number and prolonged survival of malignant tumor patients treated with radiotherapy, the complication, such as acute radiation-induced intestinal injury, has become increasingly significant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation-Induced Intestinal Injury
- What is being tested?
- Dexamethasone and Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade II-III acute radiation-induced rectosigmoid injury
- Signed informed consents
- Age ≥18 years
- Rstimated survival time >1 year
Who cannot join
- Absolute contraindications to glucocorticoids
- A history of glucocorticoids treatment within 3 months
- Inflammatory bowel disease or infectious intestinal disease
- Recurrence of malignant tumor
- Colorectal cancer or metastasis
- Severe heart or lung diseases
Show all 13Show fewer
- Recent history of surgery or trauma
- Poorly controlled hyperglycemia and hypertension
- Active tuberculosis
- Ssevere gastrointestinal ulcers
- Glaucoma
- Sychiatric diseases
- Pregnant or lactating
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, 1 recruiting
- Recruiting
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, 110840
Xingshun Qi, MD, 86-18909881019, xingshunqi@126.com
About this study
Official title: Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury: A Randomized Controlled Trial
Due to the increasing number and prolonged survival of malignant tumor patients treated with radiotherapy, the complication, such as acute radiation-induced intestinal injury, has become increasingly significant. Glucocorticoids may play a therapeutic role by regulating the inflammatory response in patients with acute radiation-induced intestinal injury. However, the conclusions of related studies were controversial.
Read the detailed description
A total of 60 patients with acute radiation-induced intestinal injury will be enrolled. They will be randomly assigned at a 1:1 ratio into glucocorticoid group and standard treatment group. The primary endpoint is the recovery and improvement of acute radiation-induced intestinal injury. The secondary study endpoints include the recurrence and aggravation of radiation-induced intestinal injury, and adverse events.
- Conditions
- Radiation-Induced Intestinal Injury
- Being tested
- Dexamethasone, Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
- Keywords
- Radiation-Induced Intestinal Injury, glucocorticoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called RHP
Retention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week.
Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulationDrug
Treatment according to guideline of radiation-induced intestinal injury.
| Study group | Role | What they receive |
|---|---|---|
| Glucocorticoids+routine treatment group | Experimental | Dexamethasone retention enema Receives: Drug: Dexamethasone; Drug: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation |
| Routine treatment group | Active comparator | Routine treatment of acute radiation-induced intestinal injury according to the current practice guideline Receives: Drug: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery and/or improvement
- If patients' clinical symptoms, including abdominal pain, diarrhea, and hematochezia, and intestinal mucosal lesions under endoscopy disappear, the recovery will be defined.
- If patients' clinical symptoms alleviate, and/or the Vienna scores evaluated by endoscopy decrease at least 1 point, the improvement will be defined.
The total number and frequency of patients who have both recovery and improvement of radiation-induced intestinal injury after treatment is calculated as the treatment efficacy.
Measured: 3 months
Secondary outcomes (2)
Recurrence and/or aggravation
Clinical symptoms related to radiation-induced intestinal injury and intestinal mucosal lesions under endoscopy recur or aggravate.
Measured: 1 year
Adverse events
Any adverse event develop.
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 posted13 May 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radiation-Induced Intestinal InjuryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
- Investigators
- Xingshun Qi, Principal investigator, The General Hospital of Northern Theater CommandXiaofeng Liu, Principal investigator, The 960th Hospital of the Chinese People's Liberation ArmyXiaohua Bao, Principal investigator, The 964th Hospital of the Chinese People's Liberation ArmyCheng Bai, Principal investigator, The 967th Hospital of the Chinese People's Liberation ArmyJunchen Ge, Principal investigator, The 962rd Hospital of the Chinese People's Liberation ArmyDongshuai Su, Principal investigator, The 963rd Hospital of the Chinese People's Liberation ArmyWenda Xu, Principal investigator, The 81th Group Military Hospital of of the Chinese People's Liberation ArmyRan Jiang, Principal investigator, The 966th Hospital of the Chinese People's Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410443
- Sponsor's protocol ID
- XHNKKY-RII-RCT
- Status last verified
- Dec 2025
- First submitted
- 30 Apr 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kochhar 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 1670631Chen W, Ma Q, Yang L, Zhang L, Zhu J, Lin W. Curative effects of montmorillonite powder combined with dexamethasone on acute radiation enteritis. Am J Transl Res. 2021 Jun 15;13(6):7270-7275. eCollection 2021.
PubMed 34306492Li Q, Liu X, Shao L, Bao X, Bai C, Ge J, Su D, Xu W, Jiang R, Mu Z, Dai H, Piao B, Zhang Y, Liang H, Yan Y, Zhang C, Xu X, Chen J, Wang J, Zhang J, Zhang J, Zhang Y, Wang J, Yang Q, Li X, Zhang X, Hou Y, Jiang R, Jin H, Qi X, Wang H. Efficacy and safety of local glucocorticoids for the treatment of acute radiation-induced intestinal injury: protocol of a multicenter randomized controlled trial. Front Pharmacol. 2025 May 30;16:1529977. doi: 10.3389/fphar.2025.1529977. eCollection 2025.
PubMed 40520206
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06410443
- Acronym / sponsor ID
- XHNKKY-RII-RCT
- Conditions
- Radiation-Induced Intestinal Injury
- Keywords
- Radiation-Induced Intestinal Injury, glucocorticoid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 May 2024 (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.
Due to the increasing number and prolonged survival of malignant tumor patients treated with radiotherapy, the complication, such as acute radiation-induced intestinal injury, has become increasingly significant. Glucocorticoids may play a therapeutic role by regulating the inflammatory response in patients with acute radiation-induced intestinal injury. However, the conclusions of related studies were controversial.
Detailed description
A total of 60 patients with acute radiation-induced intestinal injury will be enrolled. They will be randomly assigned at a 1:1 ratio into glucocorticoid group and standard treatment group. The primary endpoint is the recovery and improvement of acute radiation-induced intestinal injury. The secondary study endpoints include the recurrence and aggravation of radiation-induced intestinal injury, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoids+routine treatment group | Experimental | Drug: Dexamethasone, Drug: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulationDexamethasone retention enema |
| Routine treatment group | Active comparator | Drug: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulationRoutine treatment of acute radiation-induced intestinal injury according to the current practice guideline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Grade II-III acute radiation-induced rectosigmoid injury
- Signed informed consents
- Age ≥18 years
- Rstimated survival time >1 year
Key exclusion criteria (13 listed)
- Absolute contraindications to glucocorticoids
- A history of glucocorticoids treatment within 3 months
- Inflammatory bowel disease or infectious intestinal disease
- Recurrence of malignant tumor
- Colorectal cancer or metastasis
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 |
|---|---|---|
| DexamethasoneAlso: RHPRetention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week. | Drug | Glucocorticoids+routine treatment group |
| Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulationTreatment according to guideline of radiation-induced intestinal injury. | Drug | Glucocorticoids+routine treatment group, Routine treatment group |
Primary outcome
Recovery and/or improvement
Time frame: 3 months
1. If patients' clinical symptoms, including abdominal pain, diarrhea, and hematochezia, and intestinal mucosal lesions under endoscopy disappear, the recovery will be defined. 2. If patients' clinical symptoms alleviate, and/or the Vienna scores evaluated by endoscopy decrease at least 1 point, the improvement will be defined. The total number and frequency of patients who have both recovery and improvement of radiation-induced intestinal injury after treatment is calculated as the treatment efficacy.
2 secondary outcomes
Recurrence and/or aggravation
Time frame: 1 year
Adverse events
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 24 Dec 2025.
- 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: PubMed 34306492Chen W, Ma Q, Yang L, Zhang L, Zhu J, Lin W. Curative effects of montmorillonite powder combined with dexamethasone on acute radiation enteritis. Am J Transl Res. 2021 Jun 15;13(6):7270-7275. eCollection 2021.
- Derived from this study: PubMed 40520206Li Q, Liu X, Shao L, Bao X, Bai C, Ge J, Su D, Xu W, Jiang R, Mu Z, Dai H, Piao B, Zhang Y, Liang H, Yan Y, Zhang C, Xu X, Chen J, Wang J, Zhang J, Zhang J, Zhang Y, Wang J, Yang Q, Li X, Zhang X, Hou Y, Jiang R, Jin H, Qi X, Wang H. Efficacy and safety of local glucocorticoids for the treatment of acute radiation-induced intestinal injury: protocol of a multicenter randomized controlled trial. Front Pharmacol. 2025 May 30;16:1529977. doi: 10.3389/fphar.2025.1529977. eCollection 2025.
- 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.
Xingshun Qi principal investigator
The General Hospital of Northern Theater Command
Xiaofeng Liu principal investigator
The 960th Hospital of the Chinese People's Liberation Army
Xiaohua Bao principal investigator
The 964th Hospital of the Chinese People's Liberation Army
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation in people with Radiation-Induced Intestinal Injury, run by General Hospital of Shenyang Military Region 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. 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.
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 Xingshun Qi (18909881019, xingshunqi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery and/or improvement (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 NCT06410443, which also lists 3 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 24 Dec 2025.