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

ConditionRadiation Enteritis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorYongquan Shi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: The thalidomide groupExperimental treatment 1 intervention

Group B: The glutamine groupExperimental treatment 1 intervention

Group C: The thalidomide combined with glutamine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Treatment response rate.

The proportion of overt defecation bleeding in total defecation within 1 week after treatment was reduced by ≥50% compared with 1 week before treatment.

Time frame