Could thalidomide and glutamine heal Radiation-Damaged intestines?
NCT ID NCT06617182
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether thalidomide combined with glutamine can reduce bleeding in people with chronic radiation injury to the intestines. 150 adults who have rectal bleeding after past radiation therapy will take one or both drugs for 8 weeks. The goal is to see if the combination works better than either drug alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- thalidomide and glutamine
- What this could lead to
- If successful, this could offer a new treatment option for people with chronic radiation damage to the gut, reducing bleeding and improving quality of life.
- What could go wrong
- This is a small, early-phase trial (phase 2) with no placebo group, so results may not be definitive. Thalidomide has known side effects like drowsiness and nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2024
- Expected to finish
-
Nov 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18-80 years old, gender is not limited; * Patients with hematochezia symptoms of chronic radiation intestinal injury: Due to the lack of diagnostic gold standard for radiation intestinal injury, a comprehensive analysis of clinical, endoscopic, imaging and histopathological findings was mainly performed to make the diagnosis of radiation intestinal injury on the basis of excluding infectious and other non-infectious intestinal injuries. Exposure to radioactive sources is a necessary factor in the diagnosis of radiation intestinal injury, and tumor activity or recurrence should be excluded. * The proportion of dominant defecation bleeding in total defecation times in the week before treatment is not less than 20%; * ECOG score: 0-2. Exclusion Criteria: * Patients with hemodynamic instability; * Patients with obvious liver and kidney function injury: bilirubin, aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR\<60ml/min or dialysis patients; * Patients allergic to thalidomide or glutamine; * Patients whose primary disease was gastrointestinal malignancy; * Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.; * Female patients during pregnancy and breastfeeding (including patients with reproductive needs); * Patients infected with HIV; * Patients who cannot cooperate with regular follow-up and review of laboratory indicators; * any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Radiation enteritis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, National Clinical Research Center for Digestive Diseases, Department of Gastroenterology & Hepatology, Xijing Hospital, The Fourth Military Medical University, Xi'an, Ch
RECRUITINGXi'an, Shaanxi, 710005, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.