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Recruiting NCT06617182

Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury.

Phase II Interventional Radiation Enteritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thalidomide, Glutamine, Thalidomide+Glutamine.
Who it may be relevant to
Registry conditions: Radiation Enteritis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury: a Single-center, Open-label, Randomized Controlled Study

Overview

At present, there is still a lack of standard and effective treatment strategies and procedures for radiation intestinal injury. Studies have shown that thalidomide can effectively treat refractory gastrointestinal bleeding caused by vascular malformation. Therefore, The investigators designed a single-center, open-label, randomized controlled study to evaluate the efficacy and safety of thalidomide combined with glutamine in the treatment of radiation intestinal injury.

Detailed description

Screening: This phase will not last longer than one week, and the subject will be assessed for eligibility after signing the informed consent form.

Treatment: Subjects were randomly assigned to three different treatment groups for 8 weeks.

Follow-up: The subjects' defecation status was recorded every day during treatment, telephone follow-up was conducted every two weeks, and laboratory indicators (including blood routine, stool routine, etc.) were tested every four weeks. The test was terminated one week after treatment and the improvement of subjects' stool blood was assessed.

Interventions

  • Drug Thalidomide
    Patients in thalidomide group took thalidomide orally at a dose of 100mg once a day for 8 weeks.
  • Drug Glutamine
    In the glutamine group, two capsules of glutamine were taken orally 3 times a day for 8 weeks.
  • Drug Thalidomide+Glutamine
    Patients in thalidomide combined with glutamine group took thalidomide orally at a dose of 100mg once a day and two capsules of glutamine were taken orally 3 times a day for 8 weeks.

Primary outcome measures

  • Treatment response rate. [Time frame: From enrollment to the end of treatment at 8 weeks.]
Secondary outcome measures (7)
  • No further bleeding occurred within 1 week after treatment [Time frame: From enrollment to the end of treatment at 8 weeks.]
  • Number of blood transfusions during the treatment period [Time frame: From enrollment to the end of treatment at 8 weeks.]
  • Red blood cell input [Time frame: From enrollment to the end of treatment at 8 weeks.]
  • Hemoglobin level [Time frame: From enrollment to the end of treatment at 8 weeks.]
  • Number of hospitalizations due to bleeding [Time frame: From enrollment to the end of treatment at 8 weeks.]
  • Number of days in hospital due to bleeding [Time frame: From enrollment to the end of treatment at 8 weeks.]
  • Require surgery [Time frame: From enrollment to the end of treatment at 8 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Natio — Xi'an

Identifiers

NCT: NCT06617182 · KY20242229-F-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗